NexGen Precoat Stemmed Tibial Plate Size 5
FDA Recall Z-2092-2023 · Posted 2023-07-05
Advertisement
Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2023-05-19
Date Terminated2026-05-29
Reason for Recall
Device outer packaging was incorrectly labeled.
Firm Action
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 [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
International distribution in the country of India.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement