Z-0956-2013Class II

Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated...

Name: Z-0956-2013 Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated...
Creator: Synthes USA HQ, Inc.
Published: 2013-01-11
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-01-11 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA HQ, Inc. began a recall of Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint... on 2013-01-11. FDA classified it as Class II and gives the reason as "It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree)". 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-0956-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Posted: 2013-03-15
Terminated: 2015-08-31
Recalling firm: Synthes GmbH
Product: Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion.
Product code: HRS Plate, Fixation, Bone
Reason for recall: It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree).
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm initiated their recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter to consignees. The letter identified the affected product and the issue. Synthes requested customers to examine their inventory for the affected product, remove them from use, and return them to Synthes. Additionally, customers were to follow the steps provided in the event that they did or did not have any affected product on hand. Questions should be directed to 610-719-5450 or [email protected].
Quantity in commerce: 4
Distribution: Distributed in the states of IN, OH, PA, and TX.
Product codes and lots: Lot number 7965181

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0956-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0956-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-15

Product code HRS

K102694Class II2.4Mm Va-Lcp Dorsal Distal Radius PlatesSynthes (Usa) / cleared 2010-12-09

Process control is the most common named cause of a device recall11 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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)