Titanium Low Profile Neuro Screw — Class II medical device recall Z-1327-2016
Terminated recall by Synthes (USA) Products LLC, reported 2016-04-13, distributed nationwide. Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the
| Recall number | Z-1327-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2016-02-23 |
| Classified | 2016-04-05 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2016-09-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH |
| Reason classes | specification failure |
| Lot numbers | 9951621, 9952976, 9955377, 9958565, 9962314, 9968868, 9969645 |
| Model numbers | 400.833, 400.833E |
Product
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Reason for recall
Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.
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-1327-2016. 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.