A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone… recallZ-0882-2021 · Biomet, Inc. · initiated Dec 23, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0882-2021
- Status
- Terminated
- Initiated by the company
- Dec 23, 2020
- Posted by the FDA
- Jan 21, 2021
- Recalling firm
- Biomet, Inc.
- Quantity
- 174 systems
- Product code
- HRS
- FDA submissions
- K173767
- Distribution
- Nationwide distribution.
Product description
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.
Code information (models, lots, serial numbers)
Item: 233500004; Lot: 516349, 545167; UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- A.L.P.S.® CLAVICLE PLATING SYSTEMSOFT TISSUE GUIDE 233500004Biomet Orthopedics, LLC · Plate, fixation, bone1 recall0 reports
Other devices under the same FDA submission
2 devices cleared under K173767 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- A.L.P.S.® CLAVICLE PLATING SYSTEMCLAVICLE DEPTH GAUGE 233500003Biomet Orthopedics, LLC · Plate, fixation, bone1 report
- A.L.P.S.® Clavicle Plating System 133525110Biomet Orthopedics, LLC · Plate, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page