Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0282-2024 — RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.

U.S. FDA — Device Enforcement · United States · 2023-09-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0282-2024
Date of alert
2023-09-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Encore Medical, LP
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00888912144667
Reported risk: Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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