FDAClass IISeptember 4, 2013

Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H recall

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…

Why was Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part No. 02.111.730, with Lot No. 3614792

Product
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…
Recalling firm
Synthes USA HQ, Inc.
Quantity
11
Distribution
USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.
Recall date
September 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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