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 integrated fixation, cervical - Product Code OVE
Causa
The tcs straight hexlobular #6 drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. as a result of this malfunction, titan spine, llc is removing all of the tcs straight hex lobular #6 drivers (5210-1004) lot# g150101 from the field.
Acción
Titan Spine sent an "Urgent Medical Device Recall" letter via Fed Ex dated February 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
A replacement TCS Straight Hex lobular# 6 Drivers (5210-1004) will be shipped out to each Titan Spine Area Vice President and Sales Rep. within 4-6 weeks.
For further questions please call (262) 242-7801.
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
Screw, fixation, bone - Product Code HWC
Causa
Locking pegs were not locking during distal radius procedures. there has been one (1) report of revision surgery scheduled to remove a loosened peg.
Acción
On February 16, 2015, Flower Orthopedics generated and distributed a field memo/advisory notice (FOCMB-15-02) to all distributors with locking peg inventory on February 6, 2015. The field memo provided technique guidance to end users. All 12 consignees with remaining inventory (ie.not reported as used) were contacted directly via phone and all have agreed to ship the locking pegs back to Flower Orthopedics. Flower Orthopedics determined that a generic statement to all customers was not necessary for the following reasons detailed above and summarized again here: product was distributed only through direct channels, the health hazard evaluation has determined there is a very low risk to health, and all consignees have been directly contacted already and product inventory is being returned.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
The guide sleeve has the potential to jam in the aiming arms, which may delay disassembly and removal of instruments.
Acción
DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated March 2, 2015, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to review inventory for the affected parts and following the actions provided in the letter for removal and replacement of these devices. For questions call 610-719-5450.
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 inserter has the potential for mechanical failures such as breakage of the main shaft of the inserter for the ten, malfunction of the chuck of the inserter for the ten in the form of the chuck getting stuck/jammed, breakage of the cross bar of the inserter for the ten.
Acción
DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated February 3, 2015, to all affected customers to alert them about the recall and explain the benefits and risks associated with removing this device from the market. It stated that the immediate removal of the product would prevent the performance of emergency surgery, thus DePuy Synthes is not requiring an immediate removal of affected product(s). DePuy Synthes is in the process of developing the replacement & recovery plan for indicated devices. Due to their current but temporary lack of replacement inventory, Synthes proposed to remove and replace the device in increments to prevent any adverse impact on the availability of the device for use on patients in trauma-related surgery events.
DePuy Synthes will contact customers as replacements become available.
Customers were advised to complete the Verification Section by checking the appropriate box indicating affected product has been located. Also,indicate the number of devices found. If your facility chooses to return the product(s) at this time, please take the following additional steps:Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, include a copy of Verification Section with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.Send the completed Verification Section to the following fax or email address: Fax: (866) 782-7287 or Scan/email: Synthes5095@stericycle.com
Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant.
For questions regarding this recall call 810-719-5000.
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.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
Failures of the 4.8mm of the gap endo-exo medullary system have been identified at the level of the distal cortical screw holes. failures mainly occurred in patients with tibial pseudoarthrosis (cpt) or osteogenesis imperfecta (oi). higher failure rates have been detected in tibias with distal fractures that are close to the distal locking holes.
Acción
Pega Medical sent the Urgent Field Safety Notice-Recall/Advisory Notice letter, dated 2015/02/20, to US consignees (surgeons) via email.
The following actions were advised:
1. It is recommended to monitor patients as considered necessary in order to ensure that weight bearing does not take place until full consolidation of the fracture/osteotomy is completed and that weight bearing is applied progressively.
2. Report to the distributor or Pega Medical any adverse event observed. In cases where the consolidation has occurred, normal patient follow up can be continued with no serious consequences to the patient. In cases where consolidation has not been achieved after six weeks, replacement of the nail might be necessary.
3. All surgeons receiving this notice must acknowledge reception by a written confirmation sent to the distributor or to the contact reference person indicated below.
US consignees with questions can call Pega Medical at 450-688-5144 ext. 242, or send fax to 450-688-1977, or send email to egarcia@pegamedical.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.
Images belonging to a different patient were used for the production of the patient specific surgical guide. the incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
Acción
Materialise N.V. sent an email on February 4, 2015, to the the affected distributor regarding the reason for the recall, affected product, and instructions for removing the affected product. For questions regarding this recall call 321-639-6611.
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
Staple, fixation, bone - Product Code JDR
Causa
The firm is recalling togglelocs and ziploops manufactured in may and july of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.
Acción
Biomet sent an Urgent Medical Device Recall Notice letter dated March 4, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediate locate and discontinued use of the product and its return to Biomet. Customers may contact Field Action Specialist, Regulatory Compliance,at (574) 372-1570.
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
Staple, fixation, bone - Product Code JDR
Causa
The firm is recalling togglelocs and ziploops manufactured in may and july of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.
Acción
Biomet sent an Urgent Medical Device Recall Notice letter dated March 4, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediate locate and discontinued use of the product and its return to Biomet. Customers may contact Field Action Specialist, Regulatory Compliance,at (574) 372-1570.
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.
Zimmer, inc is voluntarily recalling 22 lots of persona¿ anterior referencing sizer with locking boom, part number 42-5099-088-10. devices are being removed from distribution due to nonconforming to print specifications.
Acción
Zimmer sent an Urgent Medical device recall letter to all customers on March 10, 2015, via letter and email. The letter identified the product, the problem, and the action to be taken by the customer. Affected units will be inspected. Units that fail inspection will be physically destroyed/scrapped. Units that pass inspection will be re-etched and redistributed. If after reviewing this notification customers have further questions or concerns they were instructed to call the customer call center at 1-877-946-2761. Hours of operation are Monday through Friday, 8:00 a.m. through 5:00 p.m. EST.
For questions regarding this recall call 574-372-4487.
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.
This lot of the reclaim assembled implant inserter adaptor instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient.
Acción
The firm issued a voluntary device removal on 02/23/2015 for lot no. SO2018074 of the RECLAIM¿ Assembled Implant Inserter Adaptor. The recall notice informs US Distributors and Medical Professionals about the issue and any actions to take. US Distributors will return affected instruments and notify one Hospital/User Facility with the Hospital Notice and Reconciliation Forms. Reconciliation forms are required for the end-user Hospital/Medical Facility Consignee. Customers may contact Mindy K. Tinsley
Director Wordwide Communications
Tel: (574) 372-7136
Fax: (574) 372-7717
E-mail: mtinsley@its.jnj.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.
It is possible for the titanium color-coded ring to detach from the reamers.
Acción
On 02/26/2015 the firm sent a Voluntary Correction Notification to its consignees via FedEx. Within that notification the firm asks to please check with your product representative and Central Supply Departments to determine if you have any of the products listed on the notificaiton. If any product is located please call 877-772-5571 from 8:30am (Eastern Time) to receive instructions as to how to remove the color-coded ring OR please follow the enclosed steps for the correction in their entirety. They contain information about returning the removed rings. Enclosed is Form 30.4 Product Tracking and Verification Form. You must complete and return this form even if you do not have any rings to remove and return. Please contact your Captiva Spine customer service representative if you have any questions regarding this correction, any of our products, or would like assistance with the correction.
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.
Incorrectly packaged. outer and inner labeling may incorrectly identify the size of the enclosed device.
Acción
Exactech Agents sent a Product Recall Advisory Notice dated February 12, 2015 by mailed to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Recall Inventory Respponse form and return it to Exactech, per the instructions provided on the notice.
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
Screw, fixation, bone - Product Code HWC
Causa
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
Acción
The firm notified their sole consignee in the US by email on 03/09/2015 requesting the return of the product, and to notify his consignee(s) to quarantine the unused product.
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
Screw, fixation, bone - Product Code HWC
Causa
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
Acción
The firm notified their sole consignee in the US by email on 03/09/2015 requesting the return of the product, and to notify his consignee(s) to quarantine the unused product.
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
Filler, bone void, calcium compound - Product Code MQV
Causa
The seal on the dbx mix outer petg/aclar tray with foil lid packaging for lot identified above may not be fully intact.
Acción
MTF notified their customers on 12/4/2014 and 12/8/2014 via phone and letter.
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.
Instrument kits for osteosponge sc grafts, osteolock facet stabilization dowel, and bacfast hd facet dowel have incorrect sterilization parameters in the ifu and on the lid of the kits. sterilization parameters for the steam gravity 121 degree c (250 f) cycle were not validated and the dry time for the steam pre-vacuum 132 degree c (270 f) cycle was omitted.
Acción
The firm, Bacterin, sent a "VOLUNTARY PRODUCT REMOVAL NOTIFICATION" letter and Steps for Voluntary Removal instructions, dated 03/03/2015, to their consignees on 3/9/2015. The letter described the product, problem and actions to be taken.
The Consignees were instructed to check with your Inventory and Central Supply Departments to determine if you have the Instrument Kit for use with OsteoLock Facet Stabilization Dowel and BacFast HD Dowel listed; immediately remove all affected product and segregate the product in a secure location for return to Bacterin International, Inc.; complete and return the Tracking Verification Form to Bacterin (even if they do not have affected product to return) to listed address, by email tkarlberg@bacterin.com or fax to 1-406-388-3380; indicate returned products on tracking/verification form; contact the firm via email at tkarlberg@bacterin.com or call 1-406-388-0480 ext. 131 from 8am to 5pm Mountain Time to obtain instructions for returning the Instrument Kits to Bacterin; package the returned goods and send to Bacterin International, Inc. 664 Cruiser Lane, Belgrade, MT 59714.
Consignees with further questions about recall, please call Regulator Affairs Manager at 406-388-9480 ext. 128 or send email to cming@bacterin.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.
Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (kinemax stem extenders, 80 mm) there was a different part #6476-8-250 (kinemax stem extenders, 40 mm.
Acción
Stryker Orthopaedics an Urgent Medical Device Recall Letter/Notification Acknowledgement Form dated April 9, 2015 to their affected customers. The recall letter identified the affected product, problem and actions to be taken. Customers are asked to contact their Stryker Orthopaedics Sales Representative to arrange for return of the product if they have any of the affected items. Customers are asked to complete and return the acknowledgement form within 5 days by emailing to: so_m_product_field_action_response@stryker.com or faxed to: 1-855-251-3635. For question 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.
Notas adicionales en la data
Wrench - Product Code HXC
Causa
Biomet is recalling the lineum hf torque handle limit (lineum) and torque limiting handle (aspen/ alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.
Acción
Biomet sent an Urgent Medical Device Recall Notice dated March 12, 2015 via phone and customer letters. The letter identified the affected product, problem and actions to be taken. Customers were asked to follow the instructions on the enclosed "Response Form". For questions call 858-232-2672.
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
Wrench - Product Code HXC
Causa
Biomet is recalling the lineum hf torque handle limit (lineum) and torque limiting handle (aspen/ alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.
Acción
Biomet sent an Urgent Medical Device Recall Notice dated March 12, 2015 via phone and customer letters. The letter identified the affected product, problem and actions to be taken. Customers were asked to follow the instructions on the enclosed "Response Form". For questions call 858-232-2672.
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.
A biomet investigation found that the low profile non-locking screw 2.7mmx22mm screw (part number: 131227222 lot: rm105e) was anodized green and should have been anodized gold per the print.
Acción
On 3/18/2015, Biomet issued an URGENT MEDICAL DEVICE RECALL NOTICE to affected distributors and one medical facility. Notification included the reason for recall, description of affected product, statement of no expected patient health risk, and actions required of the addressee. Questions related to the recall notification should be directed to (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
Plate, fixation, bone - Product Code HRS
Causa
The minor diameter, major diameter, thread pitch, and pitch on the crosscheck are out of specification, which may result in intraoperative malfunction.
Acción
Firm has initiated the recall on 03/06/2015 through written communication via Fed Ex P1 delivery to all Wright Medical Technologies distributors (hubs). Follow-up to non-responding consignees will commence 30 days after initiation. Effectiveness checks will be performed through the confirmation of returned product via a validated ERP system, a returned/signed verification form, and in the case of non-responders, a phone call, e-mail or follow up letter, depending on the region and availability of consignee.
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
Plate, fixation, bone - Product Code HRS
Causa
The minor diameter, major diameter, thread pitch, and pitch on the crosscheck are out of specification, which may result in intraoperative malfunction.
Acción
Firm has initiated the recall on 03/06/2015 through written communication via Fed Ex P1 delivery to all Wright Medical Technologies distributors (hubs). Follow-up to non-responding consignees will commence 30 days after initiation. Effectiveness checks will be performed through the confirmation of returned product via a validated ERP system, a returned/signed verification form, and in the case of non-responders, a phone call, e-mail or follow up letter, depending on the region and availability of consignee.
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
Plate, fixation, bone - Product Code HRS
Causa
The minor diameter, major diameter, thread pitch, and pitch on the crosscheck are out of specification, which may result in intraoperative malfunction.
Acción
Firm has initiated the recall on 03/06/2015 through written communication via Fed Ex P1 delivery to all Wright Medical Technologies distributors (hubs). Follow-up to non-responding consignees will commence 30 days after initiation. Effectiveness checks will be performed through the confirmation of returned product via a validated ERP system, a returned/signed verification form, and in the case of non-responders, a phone call, e-mail or follow up letter, depending on the region and availability of consignee.
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
Plate, fixation, bone - Product Code HRS
Causa
The minor diameter, major diameter, thread pitch, and pitch on the crosscheck are out of specification, which may result in intraoperative malfunction.
Acción
Firm has initiated the recall on 03/06/2015 through written communication via Fed Ex P1 delivery to all Wright Medical Technologies distributors (hubs). Follow-up to non-responding consignees will commence 30 days after initiation. Effectiveness checks will be performed through the confirmation of returned product via a validated ERP system, a returned/signed verification form, and in the case of non-responders, a phone call, e-mail or follow up letter, depending on the region and availability of consignee.