Reported Mar 6, 2013 · Terminated
Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and…
Stryker Spine
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Spine · 2 Pearl Ct · Allendale, NJ · 07401-1611
Is this the product you have?
- Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.
- Lot codes and dates
- Catalog Number48231326
- Lot Number
10G63710G638 and 10E852
- Amount recalled
- 46 units US
Where it was sold
Why it was recalled
Surgeons have experienced unthreading of the screwdrivers outer shafts during use.
This product could cause temporary or reversible health problems — stop using it.
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