NexGen Precoat Stemmed Tibial Plate Size 5
FDA device recall Z-2092-2023 · posted 2023-07-05 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Device outer packaging was incorrectly labeled.
- Action taken
- The firm distributed recall notifications by email on 5/19/2023. Customers are asked to review the recall notification and distribute to team members so they are aware of its contents. Additionally, customers are to identify and quarantine any affected devices, complete the provided Inventory Return Certification form, and ship affected product back to Zimmer. Customers are to retain a copy of the Inventory Return Certification for their records. Customers with any questions may call 574-371-3071 or email CorporateQuality.PostMarket@zimmerbiomet.com.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JWH
- Distribution
- International distribution in the country of India.
- Date initiated
- 2023-05-19
- Date posted
- 2023-07-05
- Date terminated
- 2026-05-29
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Zimmer Knee Joint Replacement Prostheses MR Labeling (K173057) | Zimmer, Inc. | 2018-03-29 |