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Variable Angle Locking Compression Plate/VA-LCP Dorsal… recallZ-0956-2013 · Synthes USA HQ, Inc. · initiated Jan 11, 2013

Class II Terminated All recalls posted in March 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes USA HQ, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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).

FDA root cause category: Labeling mix-ups

What the company is doing

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].

Recall details

Recall number
Z-0956-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 11, 2013
Posted by the FDA
Mar 15, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
4
Product code
HRS
FDA submissions
K102694
Distribution
Distributed in the states of IN, OH, PA, and TX.

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.

Code information (models, lots, serial numbers)

Lot number 7965181

Other devices under the same FDA submission

74 devices cleared under K102694 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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