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FDA Medical Device Recalls (openFDA)

Biomet, Inc.: A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.

Recall number
Z-2072-2015
Recalling firm
Biomet, Inc.
Product
A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
Status
Terminated
Initiated
2015-06-17
Posted
2015-07-14
Terminated
2016-03-22
Reason
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
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
223
Distribution
Domestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica
Lot, serial or model codes
Part Number: 816301006 Lot Numbers: 099216, 093776, 093717, 093716, 088526, 081179, 072525, 072524
510(k) numbers
not on file
PMA numbers
not on file
Product code
HYA
Firm FEI
1825034
Firm city
Warsaw
Firm state
IN
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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