Synthes, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1984-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 15, 2014

Date Posted: July 9, 2014

Recall Number: Z-1984-2014

Event ID: 68383

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.

Status: Terminated

Product Quantity: 44

Code Information:

All lots of part no. B37: 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937.

Distribution Pattern:

Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.

Voluntary or Mandated:

Voluntary: Firm initiated