DePuy Synthes Craniomaxillofacial Distraction System — Class I medical device recall Z-2148-2014
Terminated recall by Synthes, Inc., reported 2014-08-27, distributed nationwide. DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distrac
| Recall number | Z-2148-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-04-16 |
| Classified | 2014-08-19 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 1,499 |
| Lot numbers | 6245205, 6245458, 6245460, 6245462, 6245463, 6246203, 6246983, 6246984, 6251769, 6252759, 6275129, 6280719, 6307904, 6342003, 6342004, 6342005, 6342006, 6342007, 6365443, 6393118, 6393119, 6393120, 6394297, 6410544, 6410545, 6438375, 6438376, 6450702, 6454138, 6454139, 6454140, 6495399, 6512859, 6553925, 6582199, 6625839, 6625840, 6625841, 6651388, 6651389 and 160 more |
| Model numbers | 04.315.003, 04.315.004, 04.315.005, 04.315.006, 04.315.023, 04.315.024, 04.315.025, 04.315.026, 04.315.027, 04.315.028, 04.315.053, 04.315.054, 04.315.055, 04.315.056, 04.315.063, 04.315.064, 04.315.065, 04.315.066, 04.315.067, 04.315.068 |
Product
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2148-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.