—#146232

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 bones.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K070946
Affected lot / code info: Lot Number 9890811, Catalog ID 02.110.115S

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: Distributed to one customer: Colorado

Timeline

Recall initiated: 2016-05-02
Posted by FDA: 2016-06-10
Terminated: 2016-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #146232. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.