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.
FDA Recall Z-0956-2013 · Posted 2013-03-15
Advertisement
Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2013-01-11
Date Terminated2015-08-31
Product Quantity4
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).
Firm 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].
Root Cause
Labeling mix-ups
Distribution Pattern
Distributed in the states of IN, OH, PA, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement