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

FDA device recall Z-1949-2016 · posted 2016-06-10 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

Reason for recall

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.

Action taken

DePuy Synthes sent out an Urgent Notice to customers informing them of a package mixup and the impact it could have on users. Customers were asked to evaluate their inventory and immediately remove the affected lot (9890811) from stock. Customers were asked to call DePuy Synthes at 1800-479-6329 to obtain a Return Authorization Number for return of the affected product, fill out the verification section of the letter and mail with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Any questions, they were said to call 610-719-5450 or to contact their DePuy Synthes Sales Consultant.

Root cause

Under Investigation by firm

Status

Terminated

Product code

HRS

Quantity affected

6 units

Distribution

Distributed to one customer: Colorado

Date initiated

2016-05-02

Date posted

2016-06-10

Date terminated

2016-12-09

Location

West Chester, PA

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