Z-0590-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 19, 2018
- Initiation Date
- October 10, 2018
- Termination Date
- April 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 total
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.
Distribution Pattern
Distributed to accounts in IN, MD, MO, MS, and NM.
Code Information
068390