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Open, Classified

AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

FDA Recall Z-3195-2026 · Posted 2026-09-16

Recalling FirmHowmedica Osteonics Corp.
Recall StatusOpen, Classified
Product CodeJDC
Date Initiated2026-07-30
Product Quantity12,156 US

Reason for Recall

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Firm Action

Firm began notifying customers on July 30, 2026, via FedEx 2-day air. Customers were instructed to quarantine and discontinue use of the affected product. Affected product should be returned to the firm.

Root Cause

Process change control

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980502OSTEONICS TOTAL ELBOW SYSTEMOsteonics Corp. · 1998-05-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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