Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and
FDA device recall Z-2032-2014 · posted 2014-07-10 · Terminated
Recall details
- Recalling firm
- Zimmer Manufacturing B.V.
- Reason for recall
- Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.
- Action taken
- Zimmer sent an Urgent Medical Device Recall Lot specific letter dated June 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. Please locate, quarantine, and return the affected product (part number 00-4840-020-00 lot number 62629432 and part number 00-2347-022-14 lot number 62628759) from all inventories. 2. Please note that any hospitals that received direct shipments of this product from Zimmer will be notified via Fed Ex. 3. Please review the list of hospital and surgeons to be provided to your territory via email. 4. Provide the name, address, and phone number of any additional hospitals or surgeons that may have received or used the affected product, or confirm that the list provided is complete. 5. Complete and return Attachment 1. 6. Ensure that a copy of the Risk Managers and Surgeons letter is left with the facilities from which product is removed by providing them with a copy of the letter, if they are not identified as a facility receiving a letter directly from Zimmer. 7. If after reviewing this notification you have questions or concerns, please contact Zimmer at 1-877-946-2761.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 496
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and Canada.
- Date initiated
- 2014-06-12
- Date posted
- 2014-07-10
- Date terminated
- 2015-06-24
- Location
- Mercedita, PR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRILOGY ACETABULAR SYSTEM (K934765) | Zimmer, Inc. | 1994-04-29 |