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.
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 recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
Acción
FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated December 11, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to utilize the sterilization cycles included in the letter. Customers were further advised to alert users of these devices to the sterilization process changes. Customers with questions can contact Brainlab by telephone at 800-597-5911 or via e-mail at us.support@brainlab.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.
The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.
Acción
Biomet issued written notices on 1/7/2015, Requested completion and submission of response/effectiveness forms for Product Part Number: 01 0000589 Product Description: Comprehensive Reverse Shoulder Glenosphere Mini
Baseplate 25mm with Taper Adapter, Expiration October 2024. Questions related to this notice should be directed to Audrey Daenzer, Field Action Specialist (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
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
Stryker is recalling system 6 aseptic housing, due to a failed continuous bond line test from a housing without a continual weld. customers are instructed to return recalled product to stryker.
Acción
Stryker sent notice to customers via Fed ex overnight on 1/16/2015, regarding its voluntary recall of Stryker System 6 Aseptic Housings because the laser welder may have failed to produce a continuous bond line for the four specific lots: 13205, 13209, 13210, 13212. Customers are instructed to discontinue use, complete the business reply form, and return all recalled product. Customers may contact Kara Spath at 269-389-4518, or kara.spath@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.
Three customer complaints were received for the same batch of v40 lfit vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding v40 stem trunnion.
Acción
Branches/Agencies were notified of this action by e-mail on December 19, 2014 and were asked to quarantine affected devices. Notification Letters and Product Accountability Forms were sent to Hospital Risk Management and Chief of Orthopaedics via FedEx (with return receipt) by 2/3/2015.
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 weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the distal capture assembly.
Acción
On March 20, 2015, Stryker sent Urgent Medical Device Recall Notifications/Urgent Medical Device Recall Notification Acknowledgement Forms dated March 19, 2015 to all affected customers. The letter identified the product, the related issue and the action to be taken by the customers. Customers were asked to return the attached acknowledgement form confirmed they received and reviewed the notification. Customers with questions were instructed to call 201-831-6365.
Stryker sent an Urgent Medical Device Correction letter dated February 11, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to return the attached acknowledgement form confirming they have received and reviewed the letter. Customers with questions were instructed to call 201-831-6365.
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.
When using the makoplasty partial knee arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated.
Acción
On January 22, 2015 the firm sent an IMPORTANT MEDICAL DEVICE CORRECTION asking consignees to complete the attached acknowledgement form and return them by email, fax or mail. The notice also noted the RIO system can continue to be used. The likelihood of occurrence is rare (.035% of cases) and the event is readily detectable and can be resolved. Should you have any questions regarding this Important Medical Device Recall Notice, to contact us at (954) 628-1721.
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 telluride percutaneous rod inserter long does not contain a feature that locks the rod in place during use. there is a potential for the rod to disengage from the inserter during insertion, and could lead to harm to the patient.
Acción
Consignees were informally contacted 12/16/2011 of units in the field requesting retrieval. All units were in Lanx's (Biomet's) possession at the time of the recall initiation on 12/19/2011.
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
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Causa
Biomet spine, llc is recalling the timberline cranial caudal and posterior blades, 40-180mm due to oversize of the set screw hex feature.
Acción
Biomet initiated the recall on February 22, 2012, No letters were or will be sent to customers. 100% retrieval was achieved by working directly with the customers.
For questions regarding this recall call 303-501-8548.
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.
Biomet spine llc is recalling the set screw 5.5 mm rod due to the set screw being out of specification.
Acción
Biomet Spine LLC (formerly Lanx) sent an Urgent Recall Notification letter to affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Lanx Customer Service.
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.
Possibility that the patient label inside the product box was incorrectly labeled. the outer box label and actual product are correctly identified but the internal patient label could be incorrect.
Acción
On June 5, 2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers via email and Fed Ex courier service. ***Risk Managers are advised to: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative to quarantine all affected product. 3. Work with your Zimmer Biomet sales representative in removing the affected product from your facility. 4. Confirm that the patient labels in your records are correct. 5. Complete the Certificate of Acknowledgement and return a digital copy to corporatequality.postmarket@zimmerbiomet.com and retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilities documentation. ****Distributors, Sales Reps & Distributor Operation Managers are advised to: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form and return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet.
a. Request a Recall Return Authorization Number via SMS or via email to rgarequest@zimmerbiomet.com (domestic) or via email to zimmerbiometintlirarequests@zimmerbiomet.com (international).
b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Mark the outside of the returns box(es) clearly with RECALL.
Customers with further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5
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 compromise of the inner sterile tray. if a compromised tray is detected, a delay in surgery may result. if undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Acción
On 12/17/2014, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers 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.
Potential compromise of the inner sterile tray. if a compromised tray is detected, a delay in surgery may result. if undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Acción
On 12/17/2014, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers 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.
Potential compromise of the inner sterile tray. if a compromised tray is detected, a delay in surgery may result. if undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Acción
On 12/17/2014, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers 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
Accessories, fixation, spinal intervertebral body - Product Code LYQ
Causa
The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
Acción
On January 12, 2015, the Sales Managers and Sales Force were notified by Post-Market Quality regarding the imminent notification and follow-up activities. The recall notices were delivered to the Risk Managers at impacted consignee sites on January 13, 2015. These recall notices included a Risk Manager Letter informing them on the action, and a consignee-specific questionnaire to indicate their product on-hand.
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.
Biomet recalled the mallory head 4 finned acetabular shell 50mm (lot 364600) and ringloc + acetabular shell limited hole finned 52 mm (lot 427840) following a mix up in packaging with the two.
Acción
Biomet notified all domestic and foreign customers via FEDEx overnight on 1/9/2015. Response forms were provided, customers were instructed to notify hospital personnel if product was further distributed, and remove recalled products from circulation. Replacement parts were made available, customers may contact Audrey Daenzer, Field Action Specialist, Regulatory Compliance
Biomet, Inc., audrev.daenzer@biomet.com, or 574-372-1570 Monday- Friday 8 AM to 5 PM.
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.
Biomet recalled the mallory head 4 finned acetabular shell 50mm (lot 364600) and ringloc + acetabular shell limited hole finned 52 mm (lot 427840) following a mix up in packaging with the two.
Acción
Biomet notified all domestic and foreign customers via FEDEx overnight on 1/9/2015. Response forms were provided, customers were instructed to notify hospital personnel if product was further distributed, and remove recalled products from circulation. Replacement parts were made available, customers may contact Audrey Daenzer, Field Action Specialist, Regulatory Compliance
Biomet, Inc., audrev.daenzer@biomet.com, or 574-372-1570 Monday- Friday 8 AM to 5 PM.
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.
May contain small amounts of ethylene glycol residue.
Acción
ConForMIS issued a Press on August 31, 2015 to the general public The sales force was notified through email. The sales personnel for affected accounts that had upcoming surgeries scheduled were asked to confirm that the affected surgeries were cancelled and that the devices were not used in surgery (Formal notification letters will be distributed to the affected accounts by Tuesday, September 8, 2015. The user required to confirm their understanding of the recall and to return any unused product to ConforMIS. Distribution of the letters conducted in two phases as described below:
Phase 1-Surgeons with product for which the surgery has not yet been completed
Phase 2-Surgeons for whom product was confirmed to have been
consumed/implanted. An updated Surgeon letter dated September 8, 2015 issued includes additional information for devices that have been used in surgery.
Contact your local ConforMIS representative or Amita Shah, at 17813459164.
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.
Some units of the evolution tibial base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.
Acción
MicroPort Orthopedics sent an Urgent Action Required letter dated January 29, 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 check their stock including all consignment stock to determine if they have any affected product. If they have affected product they should return immediately to the MicroPort Orthopedics Inc. Distribution Center at 11481 Gulf Stream, Arlington, TN 38002. Mark all return shipping boxes with "RECALL" for identification and processing. Customers with questions were instructed to contact MPO's Customer Experience Department at 1-866-872-0211. For questions regarding this recall call 901-867-4324.
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
Bone cement, antibiotic - Product Code MBB
Causa
One lot of smartset ghv gentamicin bone cement is partially agglomerated . this may result in surgical delays while a replacement package of cement is retrieved and mixed.
Acción
DePuy Orthopaedics, Inc. sent an Urgent Information - Recall Notice dated February 6, 2015, to all affected consignees for a voluntary recall of one lot of SMARTSET¿ GHV Gentamicin Bone Cement because the affected cement is partially agglomerated (clumped together). Consignees were instructed to discontinue use of the affected lot of bone cement immediately and destroy according to the consignees hazardous materials protocol or return if Certified Dangerous Goods Shipper, holding an International Air Transport Association (IATA) certification. Customers were instructed to call 574-371-4917 (M-F; 8 am 5 pm EST).
For questions regarding this recall call 574-371-4577.
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.
Pmma coating does not meet specifications. area of the stem may be missing pmma coating.
Acción
Zimmer sent an URGENT MEDICAL DEVICE RECALL - Lot Specific letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Your Responsibilities
1. Review the notification and ensure affected personnel are aware of the contents.
2. Locate and remove from inventory the affected products identified above.
3. Return any affected product with missing PMMA coating per the PER process
4. Return the Notification Acknowledgment Form (Attachment 1) to corporatequality.postmarket@zimmer.com.
5. Please notify Zimmer if the hospital that you have distributed the affected product to has implanted the product. In
addition, identify the surgeons that have used this product.
6. If after reviewing this notification you have further questions or concerns please call the customer call center at
1-877-946-2761 between 8:00 am and 5:00pm EST.
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 compromise of the inner sterile tray. if a compromised tray is detected, a delay in surgery may result. if undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Acción
On 12/17/2014, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers 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.
Potential compromise of the inner sterile tray. if a compromised tray is detected, a delay in surgery may result. if undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Acción
On 12/17/2014, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers 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
Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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.
An increase in complaints of loosening and radiolucent lines.
Acción
Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution. Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on 2/16/2015 via mail. Customers are asked to review the notification and ensure affected personnel are aware of the contents. All affected product are to be located and quarantined immediately. The Inventory Return Certification Form should be completed and returned along with the recalled product. Customers may contact the following with any questions: 1-877-946-2761 between 8:00 am and 5:00pm EST.