Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine… — Class I medical device recall Z-0226-2015
Terminated recall by Synthes (USA) Products LLC, reported 2014-12-03, distributed in CO, MI, MT. Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have bee
| Recall number | Z-0226-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2014-10-23 |
| Classified | 2014-11-26 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2015-08-10 |
| Distributed | CO, MI, MT |
| Quantity | 24 |
| Lot numbers | 6816781 |
| Model numbers | 04.634.002 |
Product
Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5).
Reason for recall
Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification.
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-0226-2015. 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.