Food, drugs, devices › Synthes, Inc.
Device recall: Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Synthes, Inc. (West Chester, PA) initiated this device recall on 10 Apr 2014; FDA lists 1 product record under event 68072, classified Class II.
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 26 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
"Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe."
Distribution
"Worldwide Distribution - USA (nationwide) and Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1833-2014 | Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components. | 5,114,052 | Class II | Terminated | 25 Jun 2014 |
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: "Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe."
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 - USA (nationwide) and Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 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.