FDA Device recall Z-2148-2014
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
- FDA Device
- Class I
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class I recall of DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) by Synthes, citing 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-op….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2148-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-04-16 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | US |
Product
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
Reason
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.
Identifiers
| code_info | Part nos. 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 0…Part nos. 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, with lot nos.: 6245205, 7129328, IS10400 6246203, 6582199, 6794535, 6814674, 6877737, 6921359, 6981567, 7008430, 7081952, 7129329, 7460419, 7556148 6246984, 6342006, 6964974, 7129330, 7460420, 6246983, 7389334, 7422735, 7515818 6245460, 6342005, 6454138, 6495399, 6651393, 6816023, 6898959, 6921360, 7306561, 7515824 6307904, 6365443, 6410544, 6438375, 6625839, 6651392, 6984928, 7241620, 7351855, 7390470, 7408179, 7458272, 7458273, 7458274, IS10394 6450702, 6454139, 6553925, 6625840, 6883404, 6921586, 7031344, 7185897, 7389329, 7408181, 7422706, 7422707, 7422708, 7458299, 7515832, IS10385 6393118, 6393119, 6410545, 6454140, 6512859, 6625841, 6651391, 6984925, 7185895, 7408182, 7422703, 7422704, 7422705, 7515829, 7515830 6393120, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2148-2014%22
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