Bone Dowell Harvest Tubes

FDA device recall Z-2059-2017 · posted 2017-04-25 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.

Action taken

On 4/12/2017 URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via e-mail. 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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LXH

Quantity affected

49

Distribution

No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND

Date initiated

2017-04-12

Date posted

2017-04-25

Date terminated

2017-11-03

Location

Warsaw, IN