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Terminated

Bone Dowell Harvest Tubes

FDA Recall Z-2059-2017 · Posted 2017-04-25

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2017-04-12
Date Terminated2017-11-03
Product Quantity49

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.

Firm Action

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

Distribution Pattern

No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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