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Howmedica Osteonics Corp.: TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Medical DevicesSource: FDA (device) · Date: 2026-09-23

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Howmedica Osteonics Corp.
Product
TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
Recall initiated
2026-07-30
Code info
620-00-28D UDI-DI 07613327313581 Lots MHANP2 MHD1N0
Product quantity
12,156 US
Voluntary mandated
Voluntary: Firm initiated
City
Mahwah
State
NJ
Country
United States
Event id
99558
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