Reported Jun 10, 2015 · Terminated
3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm…
Synthes, Inc.
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: Synthes, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
- Lot codes and dates
- Part Number 310.65 310.67 310.221 lot numbers
PE00966PE01000PE01039PE01058PE00959PE00968PE00974PE00998PE01006PE01011PE01048PE00971PE01059PE01040
- Part Number 310.65 310.67 310.221 lot numbers
- Amount recalled
- 1495 US (37 OUS)
Where it was sold
- Nationwide
Why it was recalled
affected parts and lots of the Cannulated Drill Bits have the potential to break during use
This product could cause temporary or reversible health problems — stop using it.
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