Food, drugs, devices › Synthes, Inc.
Device recall: The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
FDA enforcement event 67560 is a device recall by Synthes, Inc. of West Chester, PA, initiated 11 Feb 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 10 Sep 2015. 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
"The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22."
Distribution
"Worldwide Distribution - USA Nationwide Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1457-2014 | The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures. | 20 | Class II | Terminated | 23 Apr 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: "The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22."
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 Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Sep 2015. "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.