Z-0591-2019 Class II Terminated
FDA device recall Z-0591-2019 was initiated by Zimmer Biomet, Inc. on Oct 10, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 28, 2020). Affected quantity: 3 total.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 19, 2018
- Initiation Date
- Oct 10, 2018
- Termination Date
- Apr 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 total
Product Description
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 Pattern
Distributed to accounts in IN, MD, MO, MS, and NM.
Code Information
568150
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0591-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026