FDA Device recall Z-1685-2013
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated…
- FDA Device
- Class II
- terminated
- Published 2013-07-17
On 2013-07-17 the FDA classified a Class II recall of Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated… by Integra Lifesciences, citing the firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1685-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-01 |
| Published | 2013-07-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
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
The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
Identifiers
| code_info | The following lots of the cannulated screw driver (model number P/N 129733ND) were affected: D2ZG, D32L, D3HV, D3PG and…The following lots of the cannulated screw driver (model number P/N 129733ND) were affected: D2ZG, D32L, D3HV, D3PG and E0U3. The following lots of the cannulated screwdriver tip (model number P/N 129735ND) were affected: D2ZQ and D3EC. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1685-2013%22
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