medical MODERATE Updated 2026-09-23

Howmedica Osteonics Corp. recalls TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaed

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 620-00-28D UDI-DI 07613327313581 Lots MHANP2 MHD1N0

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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