FDA-Device2018-12-19Class II
Comprehensive Mini Stem, Item No. 113631:
Zimmer Biomet, Inc.
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.
Sold states
Distributed to accounts in IN, MD, MO, MS, and NM.
Affected count
3 total
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Comprehensive Mini Stem, Item No. 113631:
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0591-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief