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Terminated

A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.

FDA Recall Z-2072-2015 · Posted 2015-07-14

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHYA
Date Initiated2015-06-17
Date Terminated2016-03-22
Product Quantity223

Reason for Recall

Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.

Firm Action

On 6/17/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for locating and returning the affected product. 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. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Root Cause

Vendor change control

Distribution Pattern

Domestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica

Official Source

View FDA Recall →

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

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