S4C Occiput Torque Wrench F/Set Screw — Class II medical device recall Z-2326-2015
Terminated recall by Aesculap, Inc., reported 2015-08-12, distributed nationwide. A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during impla
| Recall number | Z-2326-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap, Inc., Center Valley, PA, United States |
| Recall initiated | 2015-07-07 |
| Classified | 2015-08-03 |
| Reported by FDA | 2015-08-12 |
| Terminated | 2017-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 10 |
| Reason classes | device malfunction |
| Lot numbers | S4C |
Product
S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.
Reason for recall
A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not include instructions for reassembly after reprocessing.
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-2326-2015. 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.