Food, drugs, devices › Synthes, Inc.
Device recall: Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026.
FDA enforcement event 68383 is a device recall by Synthes, Inc. of West Chester, PA, initiated 15 May 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 Dec 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
"All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label."
Distribution
"Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1984-2014 | Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic. | 44 | Class II | Terminated | 9 Jul 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: "All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label."
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: "Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Dec 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.