Malibu Polyaxial Screwdriver — Class II medical device recall Z-0938-2014
Terminated recall by Integra LifeSciences Corp., reported 2014-02-19, distributed in AZ, CA, FL, IA, IL, LA, MD, NC…. Integra LifeSciences has identified through an investigation of complaints that there may be the potential for
| Recall number | Z-0938-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2014-01-22 |
| Classified | 2014-02-07 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2014-12-17 |
| Distributed | AZ, CA, FL, IA, IL, LA, MD, NC, NM, TX, VA |
| Countries outside the US | ZA |
| Quantity | 40 |
| Reason classes | device malfunction |
| Lot numbers | 91-2109, 91-2110, AL546768F, AL549784F, AL552404F |
| Model numbers | 510, 91-2109, 91-2110, AL549784F |
Product
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.
Reason for recall
Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some complaints did indicate the surgery was slightly prolonged while the additional driver provided in the kit was retrieved and used.
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-0938-2014. 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.