Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
Reported: December 19, 2018 Initiated: October 10, 2018 #Z-0590-2019
Product Description
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
Reason for Recall
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 3 total
- Distribution
- Distributed to accounts in IN, MD, MO, MS, and NM.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394. Recalled by Zimmer Biomet, Inc.. Units affected: 3 total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2018. Severity: Moderate. Recall number: Z-0590-2019.
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