Biomet ExploR Radial Stem Recalled for Missing Threads
Biomet is recalling eight ExploR 7x26mm Modular Radial Stem implants because missing wedge ramp threads may cause set screw loosening, potentially requiring revision surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that increases the risk of intraoperative set screw loosening and potential revision surgery, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling eight units of the ExploR 7x26mm Modular Radial Stem, catalog number 11-210062, lot number 972230. These are elbow prosthesis orthopedic implants. The devices were distributed nationwide in New York, Maryland, North Carolina, South Carolina, Michigan, Oregon, and Nevada.
The recall is due to a potential manufacturing defect where the wedge ramp threads may be missing from the stem. If these threads are absent, the likelihood of the set screw loosening from the radial stem during surgery is increased. If the set screw loosens, a revision surgery may be necessary.
Healthcare providers and patients who have received this specific implant should contact Biomet, Inc. for further instructions regarding the recall and potential replacement or revision.
The recalled product
- Product
- ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
- Manufacturer
- Biomet, Inc.
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 11-210062 Lot Number Identification: 972230
Distribution
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