Z-0882-2021Class II

A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 -

Name: Z-0882-2021 A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 -
Creator: Biomet, Inc.
Published: 2020-12-23
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-12-23 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions... on 2020-12-23. FDA classified it as Class II and gives the reason as "The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0882-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-23
Posted: 2021-01-21
Terminated: 2023-04-13
Recalling firm: Zimmer GmbH
Product: A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
Root cause tag: design
FDA root cause: Device Design
Action: On 12/30/2020, Zimmer Biomet issued an Urgent Medical Device Recall to the consumer/user level, including any intermediate wholesale or retail consignees. All distributors will be notified via email. Hospital risk managers and surgeons, as well as distributors with product, will be notified via courier.
Quantity in commerce: 174 systems
Distribution: Nationwide distribution.
Product codes and lots: Item: 233500004; Lot: 516349, 545167; UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0882-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0882-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-21

Product code HRS

K173767Class IIA. L. P. S. Clavicle Plating SystemBiomet, Inc. / cleared 2018-04-06

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)