Synthes Synapse SD Drill Guide — Class II medical device recall Z-1821-2013
Terminated recall by Synthes USA HQ, Inc., reported 2013-08-07. A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18m
| Recall number | Z-1821-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2012-10-12 |
| Classified | 2013-07-29 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2015-06-11 |
| Quantity | 2 |
| Lot numbers | 6913900 |
| Model numbers | SD389.477 |
Product
Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo
Reason for recall
A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide. The firm identified that this constituted a field action and retrospectively reported this action.
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-1821-2013. 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.