Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse Recalled by Zimmer, Inc. Due to Zimmer is initiating a lot specific recall of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer, Inc. directly.
Affected Products
Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661
Quantity: 25
Why Was This Recalled?
Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.
Where Was This Sold?
This product was distributed to 19 states: AZ, CA, CO, FL, KS, KY, MI, NV, NJ, NC, OH, OK, OR, PA, SC, TN, TX, WA, WI
About Zimmer, Inc.
Zimmer, Inc. has 437 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report