Integra Hallu-Fix cannulated screw driver — Class II medical device recall Z-1685-2013
Terminated recall by Integra LifeSciences Corp., reported 2013-07-17, distributed nationwide. The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
| Recall number | Z-1685-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2013-02-01 |
| Classified | 2013-07-11 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2013-07-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IE, IL, IT, LB, LU, NL, NO, PT, RU, SA, SE, ZA |
| Model numbers | 129733ND, 129735ND |
Product
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
Reason for recall
The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1685-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.