Food, drugs, devices › Synthes (USA) Products LLC
Device recall: Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional re
Synthes (USA) Products LLC (West Chester, PA) initiated this device recall on 31 Oct 2016; FDA lists 1 product record under event 75580, 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 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 12 Jun 2017. Initiation: voluntary: firm initiated. Synthes (USA) Products LLC has 72 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 (USA) Products LLC, West Chester, PA.
Reason for recall
"Non-conforming material used."
Distribution
"US Nationwide Distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0656-2017 | Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems. | 198 units | Class II | Terminated | 30 Nov 2016 |
Context
Other enforcement events for Synthes (USA) Products LLC
All 72 events for Synthes (USA) Products LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Non-conforming material used."
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: "US Nationwide Distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Jun 2017. "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.