FDA Device recall Z-1382-2017
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right by Matrix Surgical Holdings, citing mislabeling. The packaging labeled as left mandible contained a right mandible.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1382-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-25 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Matrix Surgical Holdings |
| Distribution | n/a |
Product
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Reason
Mislabeling. The packaging labeled as left mandible contained a right mandible.
Identifiers
| code_info | OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1382-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.