DePuy Synthes Recalls Craniomaxillofacial Distraction System Due to Reversal Risk
Synthes, Inc. is recalling specific lots of the DePuy Synthes Craniomaxillofacial Distraction System because the devices may reverse after surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (post-operative reversal) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synthes, Inc. is recalling 1,499 units of the DePuy Synthes Craniomaxillofacial Distraction System, specifically the AB Distractor Bodies and BC Distractor Bodies. The recall covers specific part numbers and lot numbers distributed nationwide in the United States.
The recall is being initiated because the affected devices may reverse post-operatively. This means the medical device could move back to its original position after the surgical procedure is completed, potentially compromising the intended medical outcome.
Healthcare providers and patients who have received these specific devices should contact Synthes, Inc. or their healthcare provider for further instructions on how to proceed. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
- Manufacturer
- Synthes, Inc.
- Affected units
- 1,499
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part nos. 04.315.003
- 04.315.004
- 04.315.005
- with lot nos.: 6245205
- 7129328
- IS10400 6246203
- 6582199
- 6794535
- 6814674
- 6877737
- 6921359
- 6981567
- 7008430
- 7081952
- 7129329
- 7460419
- 7556148 6246984
- 6342006
- 6964974
- 7129330
Distribution
Distributed nationwide across the United States.
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