Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2072-2015Class II

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

Zimmer GmbH / initiated 2015-06-17 / Terminated / root cause: supplier

Biomet, Inc. began a recall of A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number
Z-2072-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
Product
A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
Product code
HYA Forceps, Wire Holding
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.
Root cause tag
supplier
FDA root cause
Vendor change control
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.
Quantity in commerce
223
Distribution
Domestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica
Product codes and lots
Part Number: 816301006 Lot Numbers: 099216, 093776, 093717, 093716, 088526, 081179, 072525, 072524

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2072-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2072-2015Class IITerminatedVoluntary: Firm initiated