Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted… recallZ-0474-2013 · Biomet, Inc. · initiated Nov 1, 2012
Class II Terminated All recalls posted in December 2012
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 items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.
FDA root cause category: Process control
What the company is doing
Biomet, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 1, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The notification letter instructed the surgeon to montior the patient as their is a potential for increased wear which have an unknown effect on implant life. For questions call 574-372-1570.
Recall details
- Recall number
- Z-0474-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 1, 2012
- Posted by the FDA
- Dec 5, 2012
- Recalling firm
- Biomet, Inc.
- Quantity
- 4
- Product code
- KWT
- FDA submissions
- K030710
- Distribution
- USA Nationwide Distribution in the state of WI.
Product description
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Code information (models, lots, serial numbers)
Catalog Number: 113740 and Lot Number Identification: 779270
Other devices under the same FDA submission
6 devices cleared under K030710 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BIO-MODULAR SHOULDER SYSTEM 113851Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- BIO-MODULAR SHOULDER SYSTEM 11-113705Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 report
- BIO-MODULAR SHOULDER SYSTEM 113849Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- BIO-MODULAR SHOULDER SYSTEM 113896Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Bio-Modular® Shoulder System 113760Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- Bio-Modular® Shoulder System 113921Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 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 18, 2026. Text above is shown as published by the FDA.
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