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Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H… recallZ-2087-2013 · Synthes USA HQ, Inc. · initiated Jul 30, 2013

Class II Terminated All recalls posted in August 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

The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate.

FDA root cause category: Process control

What the company is doing

Synthes GMBH sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory and immediately remove the affected product from stock. Customers were advised to complete the Verification Section at the end of the letter. For questions call 610-719-5450 or contact your Synthes Sales Consultant.

Recall details

Recall number
Z-2087-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 30, 2013
Posted by the FDA
Aug 26, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
11
Product code
HRS
FDA submissions
K083694
Distribution
USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.

Product description

Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.

Code information (models, lots, serial numbers)

Part No. 02.111.730, with Lot No. 3614792

Other devices under the same FDA submission

27 devices cleared under K083694 — 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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