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Variax Screw
- Starting date:
- April 17, 2017
- Posting date:
- May 16, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63298
Reason
Stryker internally identified that the select batch of the Variax Bone Screws had been manufactured with the incorrect raw material. Screws should be grade 5 titanium [T005] but were made with grade 4 titanium [T014]. No hazards were identified. Both materials are used for Stryker Osteosynthesis implant screws and both materials have very good biocompatible characteristics. The substitution for T014 / T005 for the screws does not represent a significant incremental medical risk to the patient.
Affected products
Variax Screw
Lot or serial number
1000246276
Model or catalog number
58-17010
Companies
- Manufacturer
-
Stryker GMBH
Bohnackerweg 1,
Selzach, Solothurn
2545
SWITZERLAND