Synthes Cannulated Drill Bits Recalled for Potential Breakage During Use
Synthes, Inc. is recalling specific lots of Cannulated Drill Bits because they have the potential to break during use. The affected devices were distributed in the US and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (potential to break) in a medical device used for bone fixation, which poses a risk of significant injury.
Plain-English summary
Synthes, Inc. is recalling specific lots of 3.2 mm, 2.7 mm, and 2.0 mm Cannulated Drill Bits. The recall is due to a defect where the affected parts and lots have the potential to break during use. These drill bits are used with the Synthes Cannulated Screw, which is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
The recall involves 1,495 units in the United States and 37 units outside the US. The affected devices were distributed nationwide in the US and in Canada. Specific part numbers and lot numbers are listed in the agency's recall record.
Healthcare providers and facilities that have received these devices should stop using them and contact Synthes, Inc. for instructions on how to return the affected units.
The recalled product
- Product
- 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…
- Manufacturer
- Synthes, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
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