Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
Recall
- Recall Number
- Z-0137-2016
- Event Number
- 72366
- Firm
- Biomet Microfixation, LLC
- FEI Number
- 1032347
- Product Code
- GWO
- Status
- Terminated
- Root Cause
- Component change control
- Initiated
- August 6, 2015
- Terminated
- October 13, 2017
- Address
- 1520 Tradeport Dr, Jacksonville, FL, 32218-2480
Description
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Biomet Microfixation made phone calls on August 6, 2015 and an initial notice letter sent via FedEx on August 6, 2015, to all distributors. During the phone conversation the distributors confirmed that the inventory invoiced to them is currently in their possession and were asked to remove the lids from the trays and return them back to Biomet Microfixation. In conjunction to the Initial Notice, replacement lids were sent to their business address. Followup communication would be distributed until all units are returned to Biomet Microfixation. Distributors were instructed to do the following: 1. Immediately locate and remove from circulation the items invoiced to your account as identified on this notice. 2. Remove the lids from the quarantined units and replace with the lids (15-5001-18 or 19-5001-18) received with this Initial Notice. The new lids are being distributed to address the issue with the trays. 3. Return the lids removed from the quarantined units to Zimmer Biomet CMF and Thoracic team with the labeling information provided with this notice. RETURN THIS LID: lot number(101337 or 101~65) located on the back of the lid DO NOT RETURN NEW LID: Part numbert 15-5001-18 or 1~5001-18 respectively 4. Use the FedEx label in this packet to return the lids; this will be Zimmer Biomet's method of tracking your return. If distributors have further distributed this product, they must notify the recipient of this action by providing the recipient a copy of this notice. This letter must be given to the personnel responsible for receiving field safety notices. Please understand it is your responsibility to locate and quarantine these products. Customers with questions were instructed to call at 1-800-874-7711 or 904-741-4400, extension 9574, Monday through Friday, 8am-4pm ET.
Nationwide Distribution including CA, FL, OK, NY, NC, and IL.
5 units