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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively."
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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