Hoffman 3 Universal Pin Chucks Fixation Device
Recall Summary Stryker GmbH is recalling Hoffman 3 Universal Pin Chucks Fixation devices distributed to hospitals, pharmacies, and laboratories in New Zealand. The devices are being recalled and must be returned to the supplier. This is classified as a Class I recall, which is the most serious classification.
- Recalling firm
- Stryker New Zealand Ltd
- Product
- Hoffman 3 Universal Pin Chucks Fixation device. [Device]. Model: Chuck for Pins 3 Universal for Dia 4,5,6mm. Affected: Lot numbers - 1544AB, AN4261, AP3761, AR4000, AU0794
- Reason
- The manufacturer confirmed that certain lots of Hoffman 3 Universal Pin Chucks contained inhomogeneous coating with out-of-specification coating thickness and colour. This nonconformance was discovered via product complaints., The potential hazard associated with this nonconformance is that the parts are not fully functional. The heterogeneity of the Ni PTFE coating may accelerate degradation and compromise device performance. In addition, visible discoloration may lead users to perceive the device as unclean, contaminated, or containing debris, despite the discoloration being cosmetic only.
- 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/6c21cf30-1d1c-40d9-be6f-a85015fc37c2