U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.
Acción
Natus Medical Inc. DBA Excel-Tech Ltd (Xltek) issued medical device notification letters dated December 22, 2014 to their customers vial email and via courier service on January 2, 2015. Within the notice, customers are instructed are on to removal the previous installation and also on how to install the new program upgrade. Natus Medical Inc. has requested that the Previous Version Removed from Use Confirmation form be completed by each customer and returned. Customers who require assistance can contact Natus Technical service by calling 800-387-7516 or via email Oakville_Technical_Service@xltek.com or ots@natus.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Regulator, pressure, gas cylinder - Product Code CAN
Causa
The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death.
Acción
Western/Scott Fetzer sent an Urgent Medical Device Recall Notice notification dated January 31, 2015 to their customers via U.S. mail. The notification identified the affected product, problem and actions to be taken.
The OxyTOTE/oxyQuik/AirTOTE Distributors and Oxygen Service Providers were instructed to:
1) Notify and provide the letter to all accounts/customers to which any OxyTOTE/oxyQuik/AirTOTE products have been distributed. Alternately, please provide a list of customers who received affected product and Western/Scott Fetzer will notify them on your behalf. 2) Referring to the instructions for OxyTOTE/oxyQuik/AirTOTE Users and User Facilities, follow up with each account/customer to ensure that they locate and identify all affected product and establish the number of units in their possession subject to the recall. 3) Contact Western/Scott Fetzer to schedule remediation for any affected OxyTOTE/oxyQuik/AirTOTE product included under this notice. We will begin scheduling product for remediation on February 17, 2015. 4) Please complete the Recall Acknowledgement and Receipt Form and return it to Western/Scott Fetzer as soon as complete responses are available.
The OxyTOTE/oxyQuik/AirTOTE Users and User Facilities (Hospitals, Health Care Facilities, Health Care Service providers, etc.) were instructed to:
1) Locate and identify any OxyTOTE/oxyQuik/AirTOTE product in your possession. 2) Review the instructions to determine if the product IS or IS NOT marked and if remediation is needed. 3) Contact your OxyTOTE/oxyQuik/AirTOTE supplier or Medical Gas Provider directly to schedule the remediation of product in your possession.
For questions or concerns regarding this notification, please visit the website for additional details or contact Western/Scott Fetzer:
Website: www.westernenterprises.com/recall
By Email: recall@WesternEnterprises.com
By Phone: (800) 783-7890, extension 2516
By Fax: (440) 835-8283
By Mail: Recall Coordinator, Wester
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
real time Nucleic acid amplification system - Product Code OOI
Causa
Potential for false positive chlamydia trachomatis (ct) results and neisseria gonorrhoeae (gc) results when processing the ct qx and gc qx assays on the bd viper lt instrument.
Acción
BD sent an Urgent Field Corrective Action letter dated November 2014, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer.
Customers were advised:
a. Include the date recall was initiated, if it is already underway or the date your firm plans to start the recalling process.
b. How do you plan to notify all the consignees affected by this recall? (press release, letter, telefax, telephone, e-mail, visit, etc.)
The customer was initially contacted via a phone call and subsequently provided with a written communication.
c. How do you plan to monitor the number of consignees non-responding to the recall communication?
The single US customer was contacted by phone and provided the written communication.
d. How do you plan to do effectiveness checks of this recall? The affected instrument will be corrected.
e. Date your firm ceased further distribution of the product(s).
Product was not placed on hold. This issue does not affect new customers.
f. How do you plan to store the recall product?
BD has not requested that instruments or reagents be returned.
g. How do you plan to dispose of the recall products?
BD is not requesting that customers return the instruments or reagents.
If you require further assistance or clarification, please contact the BD Technical Services Department at 1-800 638-8663.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Prosthesis, chin, internal - Product Code FWP
Causa
Potential for implant damage, implant cracking off/breaking intra-operatively.
Acción
Stryker sent an Urgent Medical Device Recall Notice dated December 23, 2014, to all affected customers with a response form to be completed and returned upon receipt and review. The letter identified the affected product, potential hazards, risk mitigation and the actions to be taken. For questions contact Stryker CMF at 1-800-962-6558, or e-mail at CMF-custserv@stryker.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Prosthesis, chin, internal - Product Code FWP
Causa
Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
Acción
Stryker sent an Urgent Medical Device Recall Notice dated December 23, 2014, to all affected customers with a response form to be completed and returned upon receipt and review. The letter identified the affected product, potential hazards, risk mitigation and the actions to be taken. For questions contact Stryker CMF at 1-800-962-6558, or e-mail at CMF-custserv@stryker.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Motor, drill, electric - Product Code HBC
Causa
Customer complaint indicating the color bands on the mia16-g1 were not correct.
Acción
Anspach sent an "URGENT MEDICAL DEVICE RECALL" (Removal) letter dated December 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The firm requested the customer to 1) Immediately identify and set aside all product listed below 2) Review, complete, sign and return the attached reply form 3) Share this letter with others in your facility that need to be made aware of this recall 4) If you distribute any of the affected products to other services or facilities, please forward this letter as appropriate 5) Maintain awareness of this notice 7) Keep a copy of this notice.
If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Stylet, tracheal tube - Product Code BSR
Causa
A small piece of the stylet sheath has the potential to
shear off upon removal of the stylet from the tracheal tube.
Acción
URGENT: PRODUCT RECALL letters dated December 23, 2014 were sent to all customers of record. The letters included instructions for customers to: 1) quarantine the affected product; 2) notify any customers whom you may have distributed the affected product to; 3) contact the appropriate Customer Service group to arrange for return and credit of any affected product in your inventory; and, 4) complete and return the enclosed Acknowledgement Form. Customers with questions about this recall can contact Cardinal Health Quality Systems at 800-292-9332.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The wall chart has been updated because it was noted that wall chart (pn 551524-03 rev a) was inconsistent with the user manual adendum (pn 550986-07_b) with regards to neceassary sterilization dry time.
Acción
Medical Device Recall Replacement letters were sent to all customers on January 15, 2015. The letter identified the reason for the recall, the risk to health, affected products, and actions to be taken by the customer or user and the firm. Customers were asked to discard the existing EndoWrist Stapler Documentation and replace it with the new Documentation provided by the firm. Intuitive Surgical will ship replacement instruments at no charge to customers. Then customers were asked to reunite the replacement instruments with the additional components. The firm will retrain customers on the updated instructions for use. A Clinical Sales Representative or Intuitive Surgical Customer Service at 1-800-876-1310, should be contacted if further information or support is needed concerning the recall notification.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Accelerator, linear, medical - Product Code IYE
Causa
Combination of ctvision with syngo rt therapist / syngo rt oncologist 4.3.Sp1 automatic registration in adaptive targeting might result in wrong offset calculations. applying this offset can lead to patient mistreatment. cone beam imaging is not affected by this problem.
Acción
A customer advisory notice, dated January 2, 2015, was sent to end users which identified the product, problem, and action to be taken. It was recommended that customers use only manual registration with the 6 degrees of freedom option disabled, which provides the correct offset values. A software update will be deployed once a solution is available.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bilirubin (total and unbound) in the neonate test system - Product Code MQM
Causa
Neonatal bilirubin (nbili) parameter may have increased variability when the nbili concentration is greater than 12 mg/dl and the thb concentration exceeds the upper reportable range of greater than 25 g/dl.
Acción
An Urgent Field Safety Notice was sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on December 30, 2014 both in the United States and elsewhere for communication with affected customers.
In addition, all affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on December 30, 2014. All affected customers outside the US will be provided a copy of an Urgent Field
Safety Notice via hard copy, e-mail, and/or fax as determined by each countries
local regulations and procedures. This notice informs consignees of the issue. Consignees are also asked to complete a field effectiveness check form and return it Siemens via fax (312) 275-7795.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bilirubin (total and unbound) in the neonate test system - Product Code MQM
Causa
Neonatal bilirubin (nbili) parameter may have increased variability when the nbili concentration is greater than 12 mg/dl and the thb concentration exceeds the upper reportable range of greater than 25 g/dl.
Acción
An Urgent Field Safety Notice was sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on December 30, 2014 both in the United States and elsewhere for communication with affected customers.
In addition, all affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on December 30, 2014. All affected customers outside the US will be provided a copy of an Urgent Field
Safety Notice via hard copy, e-mail, and/or fax as determined by each countries
local regulations and procedures. This notice informs consignees of the issue. Consignees are also asked to complete a field effectiveness check form and return it Siemens via fax (312) 275-7795.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bilirubin (total and unbound) in the neonate test system - Product Code MQM
Causa
Neonatal bilirubin (nbili) parameter may have increased variability when the nbili concentration is greater than 12 mg/dl and the thb concentration exceeds the upper reportable range of greater than 25 g/dl.
Acción
An Urgent Field Safety Notice was sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on December 30, 2014 both in the United States and elsewhere for communication with affected customers.
In addition, all affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on December 30, 2014. All affected customers outside the US will be provided a copy of an Urgent Field
Safety Notice via hard copy, e-mail, and/or fax as determined by each countries
local regulations and procedures. This notice informs consignees of the issue. Consignees are also asked to complete a field effectiveness check form and return it Siemens via fax (312) 275-7795.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bilirubin (total and unbound) in the neonate test system - Product Code MQM
Causa
Neonatal bilirubin (nbili) parameter may have increased variability when the nbili concentration is greater than 12 mg/dl and the thb concentration exceeds the upper reportable range of greater than 25 g/dl.
Acción
An Urgent Field Safety Notice was sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on December 30, 2014 both in the United States and elsewhere for communication with affected customers.
In addition, all affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on December 30, 2014. All affected customers outside the US will be provided a copy of an Urgent Field
Safety Notice via hard copy, e-mail, and/or fax as determined by each countries
local regulations and procedures. This notice informs consignees of the issue. Consignees are also asked to complete a field effectiveness check form and return it Siemens via fax (312) 275-7795.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Pack, hot or cold, water circulating - Product Code ILO
Causa
Seals in the water path of the ct-99 cold therapy pad may separate during use, which could lead to a water leak.
Acción
Cincinnati Sub-Zero sent an Urgent Medical Device Recall Field Action Notice dated January 7, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use and/or further distribution of the affected product. Customers were instructed to obtain a Return Material Authorization Number and return the pad(s) for exchange. Customers with questions were instructed to call 1-800-989-7373 or 513-772-8810. Customers were also asked to commplete and return the enclosed Response Form as soon as possible by fax to (513)772-9119 to acknowledge receipt of the notification and to inform CSZ that they have performed the requested actions.
For questions regarding this recall call 513-772-8810, ext 6816
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, nuclear magnetic resonance imaging - Product Code LNH
Causa
The mri system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
Acción
Altech Medical Systems America Inc., notified customers on January 9, 2015, of the problem via telephone. Customers were instructed to immediately cease using the product until the correction can be made. A follow-up letter was sent through the mail, which stated that a service engineer would make a site visit to ramp down the magnet until the issue can be corrected. Customers were asked to complete the attached Acknowledgement and Receipt Form and fax it to (440) 424-2255. For questions contact AMSA at 1-855-200-2672.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, nuclear magnetic resonance imaging - Product Code LNH
Causa
At certain sites, the mru may not be connected to the magnet. in emergency situations, a disconnected mru could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. the mru must be connected to the magnet at all times.
Acción
GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref# 60876 dated January 6, 2015 to affected consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. Customers were instructed to do the following:
As a preventative measure, confirm that MRU is connected to the magnet by performing the following four step test on the MRU.
1. Verify the green CHARGER POWER LED is lit.
2. Depress and hold the TEST BATTERY switch for 15 seconds. The green BATTERY TEST LED should light and remain lit while the TEST BATTERY switch is depressed.
3. Place the TEST HEATER toggle switch in the A position. The green HEATER TEST LED should light. If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning.
4. Place the TEST HEATER toggle switch in the B position. Green HEATER TEST LED should light. If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning.
If the MRU test does not perform as described in each of the 4 steps above, GEHC strongly recommends that you stop using the system, and immediately call your GEHC representative.
Customers with questions may contact their local service representative.
For questions regarding this recall call 1-800-437-1171.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for fracture of the tip of the product. the fractured tip is approximately 4mm x 7mm x 3.5mm in size. retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; revision surgery to remove the fractured tip.
Acción
On 11/25/2014, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected distributors, hospital Risk Managers and Surgeons with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers, Surgeons, and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call the customer call center at 1-800-348-2759.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wrap, sterilization - Product Code FRG
Causa
Advanced sterilization products (asp) is recalling the tyvek rolls with sterrad chemical indicator because they were shipped to customers after its expiration date of may 18, 2013.
Acción
A customer notification letter was sent on 12/24/14 to all customers who purchased the expired Tyvek Rolls with STERRAD Chemical Indicator. The letter informs the customers of the problems identified and the actions to be taken.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Needle, catheter - Product Code GCB
Causa
An incorrect item number is packed within the outside "piggybacked" package. the interior sealed sterile kit is correct and no adverse issues affect that part of the item. the non-sterile outside "piggybacked" package mistakenly contains item #8881579121 - syringe prefilled, saline flush, 09% sodium chloride and is a nonsterile product that cannot be dropped into the sterile field.
Acción
Custom Healthcare System sent an Urgent Product Recall letter dated November 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
PLEASE CHECK YOUR INVENTORY AND QUARANTINE ANY AFFECTED PRODUCT MATCHING THE DESCRIPTIONS ABOVE. Call 804 (421-5959) with regards to returning the affected products. Return Authorizations will be issued and product pickup and return will be scheduled.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Apparatus, gas-scavenging - Product Code CBN
Causa
A calibration problem was detected in a specific number of the servo-i ventilator system co2 analyzer models that may have been caused by the module's internal circuit board function.
Acción
Maquet sent an Urgent Product Recall Medical Device Action Field Removal Letter dated 1/12/2015 via FedEx.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Ventilator, continuous, facility use - Product Code CBK
Causa
Covidien is issuing a voluntary field action for all puritan bennett 980 ventilators due to occasional gui transient resets that last approximately 30 seconds.
Acción
Covidien sent an Urgent Field Safety Notice on January 12, 2015, to all affected customers. Customers were requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Covidien is updating software that will modify ventilator alarms and status display messages during a GUI reset. The Puritan Bennett 980 Ventilator Operator Manual will be updated to delete,replace ventilator during a GUI transient reset, and to inform users to monitor the secondary status display until the primary display refreshes. Covidien will communicate with customers when the software and operator manual updates are available.
Customers with questions were instructed to contact Technical Support Department at 800-255-6774, option 4, and then option 1.
For questions regarding this recall call 303-876-8870.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Table, radiologic - Product Code KXJ
Causa
The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality.
Acción
Planned Action by the firm:
1. You will send out a customer notification letter that identified the software corrective actions and that indicates that these corrective actions will be provided to the end-user free of charge.
2. You will implement a corrective software patch so that kV and mA manual adjustments from the generator console are inhibited, and consequently no high-level control modality is allowed. In AERC, high-level control is already disabled. A Field Service Engineer is to implement the software patch according to the corrective action plan
1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR
The system shall be modified upgrading the generator power firmware which will inhibit the high-level control bringing the system into compliance.
This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification.
2. You will implement the corrective software patch to inhibit high-level control according to the corrective action plan by June 22, 2015.
For further questions please 203.262-8836
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for delay in surgery and/or ball bearings to be left in the wound. repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. to prevent this, tasp shims must be manually cleaned and inspected per product insert, 87-6203-991-22.
Acción
Zimmer sent an URGENT MEDICAL DEVICE CORRECTION notifications letter dated December 11, 2014 to affected distributors via electronic mail, and all hospital Risk Managers and distributors with affected inventory via courier. The letter identified the affected product, problem, instructions for responding to the formal recall notification.and actions to be taken. For questions call the customer call center at 1-800-348-2759.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Causa
In may 2013, the original recall was initiated due to complaints the hand switch for the electric pen drive was not labeled correctly, and the on and lock labels were interchanged.
Acción
Synthes sent an Urgent Medical Device Recall Notice, dated December 19, 2014, to all affected customers to provide updated information on additional lots identified. Customers were instructed to examine their inventory for the affected product, remove from inventory, and return them to Synthes immediately for replacement. Customers were instructed to call Synthes to obtain a Return Authorization (RA) Number, complete the Verification Section at the end of the letter, and return the Verification Form with the product to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, CO 80132. Customers with questions were instructed to call 610-719-5450 or email FieldAction@synthes.com. For questions regarding this recall call 610-719-5000.