Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
Published December 19, 2018 · Recall initiated: October 10, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Distributed to accounts in IN, MD, MO, MS, and NM.
- Lot
- 068390
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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