ExploR 7x26mm Modular Radial Stem, Catalog number… recallZ-1615-2014 · Biomet, Inc. · initiated Apr 22, 2014
Class II Terminated All recalls posted in May 2014
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
This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.
FDA root cause category: Process control
What the company is doing
Biomet sent an URGENT MEDICAL DEVICE SAFETY ALERT dated April 22, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Recall details
- Recall number
- Z-1615-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 22, 2014
- Posted by the FDA
- May 13, 2014
- Recalling firm
- Biomet, Inc.
- Quantity
- 8 devices
- Product code
- KWI
- FDA submissions
- K040611, K051385
- Distribution
- US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV.
Product description
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Code information (models, lots, serial numbers)
Catalog Number: 11-210062 Lot Number Identification: 972230
Other devices under the same FDA submission
15 devices cleared under K040611, K051385 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EXPLOR 11-210061Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- EXPLOR 11-210063Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER9 reports
- EXPLOR 11-210042Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER6 reports
- EXPLOR 11-210062Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER5 reports
- EXPLOR 11-210064Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER5 reports
- EXPLOR 11-210032Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER3 reports
- ExploR® 11-210099Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER3 reports
- EXPLOR 11-210033Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER2 reports
- EXPLOR 11-210041Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER2 reports
- EXPLOR 11-210022Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 report
- EXPLOR 11-210023Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 report
- EXPLOR 11-210031Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 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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