Comprehensive Mini Stem recall
Comprehensive Mini Stem, Item No. 113631:
Why was Comprehensive Mini Stem recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
568150
- Product
- Comprehensive Mini Stem, Item No. 113631:
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 3 total
- Distribution
- Distributed to accounts in IN, MD, MO, MS, and NM.
- Recall date
- December 19, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)