Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
00434811113 Recalled by Zimmer, Inc. Due to This single manufacturing lot has the potential for...
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
00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder prosthetic replacement device that is indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint as well as humeral fractures. The humeral stem uses. Trabecular Metal around the proximal part of the stem for biological ingrowth.
Quantity: 10 units
Why Was This Recalled?
This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum required by specification in one of the three zones of the Trabecular Metal. The other two zones exceeded the minimum specification.
Where Was This Sold?
Distribution USA in the state of Illinois.
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