Specialty Audible Torque Wrench Mfg by: Stryker Spine — Class II medical device recall Z-0803-2015
Terminated recall by Stryker Spine, reported 2014-12-24, distributed in GA, IN, MI, NJ, OH, PA, TX, VA. Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible
| Recall number | Z-0803-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Spine, Allendale, NJ, United States |
| Recall initiated | 2014-10-06 |
| Classified | 2014-12-15 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2017-05-08 |
| Distributed | GA, IN, MI, NJ, OH, PA, TX, VA |
| Quantity | 15 units |
| Reason classes | device malfunction |
| Lot numbers | 4279 |
| Model numbers | IS3002XLP |
Product
Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.
Reason for recall
Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in 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-0803-2015. 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.