Orthopaedic Bone Screw (non-sliding)
Recall Summary Stryker GmbH is recalling orthopaedic bone screws (non-sliding type) distributed to hospitals, pharmacies, and laboratories in New Zealand. The screws are being recalled and must be returned to the supplier. This is a Class I recall, the most serious classification.
- Recalling firm
- Stryker New Zealand Ltd
- Product
- Orthopaedic bone screw (non-sliding). [Device]. Model: VariAx2 LOCKING SCREW, Full Thread, 3.5 X L28MM. Affected: Lot number - AM5253
- Reason
- The manufacturer has confirmed that one lot of VariAx 2 Locking Screws was manufactured without the hexalobular feature required for mating with the associated screwdriver., The hazard associated with this problem is the loss of function of the implant and impaired mating with the associated screwdriver.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-05-26
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/cafcd6fe-3c14-439a-b1dc-f4ba3433e46a