Food, drugs, devices › Synthes, Inc.
Device recall: Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrum
FDA enforcement event 70018 is a device recall by Synthes, Inc. of West Chester, PA, initiated 15 Dec 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 18 Aug 2016. Initiation: voluntary: firm initiated. Synthes, Inc. has 39 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Synthes, Inc., West Chester, PA.
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."
Distribution
"Worldwide Distribution: US (nationwide) and internationally to Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0973-2015 | 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… | 1762 | Class II | Terminated | 21 Jan 2015 |
Context
Other enforcement events for Synthes, Inc.
All 39 events for Synthes, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution: US (nationwide) and internationally to Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Aug 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.