Howmedica Osteonics Corporation - Trident 0 Degree Constrained Acetabular Insert
- Recalling firm
- Stryker New Zealand Ltd
- Product
- Howmedica Osteonics Corporation - Trident 0 Degree Constrained Acetabular Insert. [Device]. Model: Multiple affected lots; Multiple affected lots; Multiple affected lots. Also covers: Constrained Liner; Howmedica Osteonics Corporation - UHR Universal Head Bipolar Component
- Reason
- The manufacturer has become aware that the devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five (5) years., Industry guidance for storage duration of UHMWPE raw material used in the manufacture of implant bearing/articulating material of prosthetic joints is less than five (5) years. Product manufactured using UHMWPE raw material beyond the recommended storage duration has the potential for elevated levels of oxidation. Oxidation of UHMWPE material can impact material properties, potentially resulting in increased wear.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-08-12
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/316f3c51-806d-4cba-90bb-143c0caa337b