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

Recall Z-0590-2019 — Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394

U.S. FDA — Device Enforcement · United States · 2018-10-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0590-2019
Date of alert
2018-10-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Biomet, Inc.
Product category
device
Product type
Devices
Reported risk: Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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