Reported Jun 9, 2021 · Terminated
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to…
Flower Orthopedics Corporation
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: Flower Orthopedics Corporation · 100 Witmer Rd Ste 280 · Horsham, PA · 19044-2647
Is this the product you have?
- T25 Cannulated Screwdrivers (CSD 025) packaged in Guide
- Wire Kits (GWK 300) - Product UsageIntended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm
- Product CodeGWK 300
- Lot codes and dates
- Lot Numbers
20033208981810220041180222000818022200051711220035
- UDI00840118110853
- Lot Numbers
- Amount recalled
- 47 units
Where it was sold
Why it was recalled
Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages
This product could cause temporary or reversible health problems — stop using it.
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