Recalls / —

—#173537

Product

Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509

FDA product code

FSM — Tray, Surgical, Instrument

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Lots: 262549 266083  1441011 M642860  2881015 3021022 3081051 266083  2591050  2771027  3231028  MJ54320  MJ54330  MJ54350  MJ54340

Why it was recalled

Lack of an adequate sterilization validation.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medical Device Recall notification letters dated 6/10/19 were sent to customers.

Recalling firm

Firm

Zimmer Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela.

Timeline

Recall initiated

2019-06-10

Terminated

2020-09-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #173537. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.