FDAClass IIJune 22, 2016

LCP Dia-Meta Volar Distal Radius Plate 15 H recall

LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small…

Why was LCP Dia-Meta Volar Distal Radius Plate 15 H recalled?

Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect. The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur.

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?

Lot Number 9890811, Catalog ID 02.110.115S

Product
LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small…
Recalling firm
Synthes (USA) Products LLC
Quantity
6 units
Distribution
Distributed to one customer: Colorado
Recall date
June 22, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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