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Recall Observatory FDA recall evidence

Device product

Comprehensive Mini Stem, Item No. 113631:

Z-0591-2019

October 10, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 81528
Status
Terminated
Classification
Class II
Quantity
3 total
Official record key
device-enforcement:Z-0591-2019

Official wording

Reason: 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.

Code information: 568150

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.