Reported Jul 1, 2020 · Terminated
Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint…
Providence Medical Technologies
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: PROVIDENCE MEDICAL TECHNOLOGIES · 3875 Hopyard Rd Ste 300 · Pleasanton, CA · 94588-8527
Is this the product you have?
- Ally Bone Screw - Product UsageBone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only
- Lot codes and dates
- Model Number; PD 32 601 -
- ALLY Bone Screw L 10mm Lot Number046164
- Model NumberPD 32 602 -
- ALLY Bone Screw L 12mm Lot Numbers045375 045646 045647 046313
- Amount recalled
- 208 units
Where it was sold
Why it was recalled
There may be dimensional manufacturing error that represents a potential safety risk to patients.
This product could cause temporary or reversible health problems — stop using it.
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