Comprehensive Reverse Shoulder System Humeral Tray Model 115340

FDA device recall Z-1103-2017 · posted 2017-02-11 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.

Action taken

On 12/20/2016, URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC notifications were sent to the affected Risk Managers and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. On 2/1/2017, URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC notifications were sent to the affected Surgeons, Risk Managers, and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The 2/1/2017 notice identified additional product lots that had been added to the affected product list, as well as included patient monitoring guidance for surgeons.

Root cause

Device Design

Status

Terminated

Product code

PAO

Quantity affected

4388

Distribution

Nationwide. CANADA AUSTRALIA CHILE COLOMBIA KOREA Netherlands

Date initiated

2016-12-20

Date posted

2017-02-11

Date terminated

2017-08-29

Location

Warsaw, IN

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