Reported Aug 31, 2022 · Completed
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Safe Orthopaedics LLC
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: SAFE ORTHOPAEDICS LLC · 700 W Irving Park Rd · Chicago, IL · 60613-1170
Is this the product you have?
- SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
- Lot codes and dates
- KITM640
Lot numbers BF0A07 and 15BF001/R10UDI 03760219910053
- KITM645
Lot number BG0A02UDI 03760219910060
- and KITM740
Lot number BL0A01UDI 03760219910091
- KITM640
- Amount recalled
- 8 devices
Where it was sold
Why it was recalled
The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.
This product could cause temporary or reversible health problems — stop using it.
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