Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP
FDA device recall Z-2552-2014 · posted 2014-08-26 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
- Action taken
- Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 972,125 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2014-07-22
- Date posted
- 2014-08-26
- Date terminated
- 2015-09-15
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEXT GENERATION KNEE SYSTEM (K933785) | Zimmer, Inc. | 1995-01-30 |