—#154985

Product

Bone Dowell Harvest Tubes

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part Number: 900738 Lot Number (LN): 889990

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND

Timeline

Recall initiated: 2017-04-12
Posted by FDA: 2017-04-25
Terminated: 2017-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154985. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.