Recall Z-0956-2013— Synthes USA HQ, Inc.

Name: FDA recall Z-0956-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-11

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-01-11, terminated 2015-08-31. It names one FDA 510(k) clearance: K102694. 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.. Reason: 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)..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Terminated: 2015-08-31
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K102694 — 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATESSynthes (Usa)·cleared 2010-12-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.