Z-1984-2014Class II

Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and...

Name: Z-1984-2014 Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and...
Creator: Synthes, Inc.
Published: 2014-05-15
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-05-15 / Terminated / root cause: labeling and UDI

FDA source

Synthes, Inc. began a recall of 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... on 2014-05-15. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1984-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-15
Posted: 2014-07-02
Terminated: 2015-12-18
Recalling firm: Synthes GmbH
Product: 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 code: HWC Screw, Fixation, Bone
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: An urgent medical device recall notice, dated May 29, 2014, was sent to end users and sales consultants to advise them of the issue and provide instructions for returning affected devices.
Quantity in commerce: 44
Distribution: Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
Product codes and lots: All lots of part no. B37: 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1984-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1984-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-02

Product code HWC

The FDA recall record names no cleared device, and no clearance has been matched to it.

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)