Malleable C- Retractor — Class II medical device recall Z-0973-2015
Terminated recall by Synthes, Inc., reported 2015-01-21, distributed nationwide. Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured f
| Recall number | Z-0973-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-12-15 |
| Classified | 2015-01-14 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2016-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,762 |
| Lot numbers | 1685602, 1695100, 1695101, 1698700, 1702300, 1706600, 1715800, 175220, 1776300, 1798900, 4688882, 4688883, 4772507, 4772508, 4814278, 4814280, 4814281, 4868678, 4868685, 4868691, 4868698, 4916060, 4916061, 4916062, 4991953, 4991962, 4992455, 5032047, 5080386, 5080387, 5129449, 5129450, 5129453, 5247085, 5247087, 5263641, 5267067, 5267068, 5287150, 5287152 and 38 more |
| Model numbers | 397.232 |
Product
Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.
Reason for recall
Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. Surgical delay may occur. Spring particles could transfer from the instrument to the patient, and may lead to an adverse tissue reaction and/or infection.
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-0973-2015. 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.