FDA recall Z-0591-2019

Product

Comprehensive Mini Stem, Item No. 113631:

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

Distributed to accounts in IN, MD, MO, MS, and NM.

Key facts

Status

Terminated

Initiation date

2018-10-10

Report date

2018-12-19

Termination date

2020-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0591-2019