Zimmer Biomet, Inc. recalls Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
- Recall date
- October 10, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0590-2019
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- Distributed to accounts in IN, MD, MO, MS, and NM.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
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