—#115544

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.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K102694
Affected lot / code info: Lot number 7965181

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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 FieldAction@synthes.com.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Distributed in the states of IN, OH, PA, and TX.

Timeline

Recall initiated: 2013-01-11
Posted by FDA: 2013-03-15
Terminated: 2015-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115544. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.