Recalls / —

—#161442

Product

14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument

FDA product code

LXH — Orthopedic Manual Surgical Instrument

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

Finished Lot order: M370490 M354450 M321540 M975460 M639280 M426760 M629950 M629930 M073530 M073540 M073550 M073560 M073570 M073580 M073590 M073600 M073610 M627490 M656470 M656580 M656590 M656600 M656610 M656620 M656640 M656660 M966880 M967050 M967060 M967070 M980260 M980270 M508490 M508410 M508500 M508450 M508480 M508520 M508470 M508510 M508460

Why it was recalled

Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.

Root cause (FDA determination)

Device Design

Action the firm took

On September 13, 2017 an URGENT MEDICAL DEVICE RECALL REMOVAL was issued to customers requesting that they review inventory and quarantine affected product, which will be immediately returned to recalling firm. Also to notify any customers who may have received product. Questions or concerns can be directed to Customer Service at 574-371-3071

Recalling firm

Firm

Zimmer Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

Distribution includes US Nationwide.

Timeline

Recall initiated

2017-09-13

Terminated

2020-04-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #161442. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.