Biomet Telluride Percutaneous Rod Inserter Long Recalled for Design Defect
Biomet Spine is recalling 10 units of the Telluride Percutaneous Rod Inserter Long because the device lacks a locking feature, posing a risk of rod disengagement during 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a surgical instrument that could lead to patient harm, meeting the criteria for a Severe rating.
Plain-English summary
Biomet Spine, LLC is recalling 10 units of the Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The device is a reusable orthopedic surgical instrument used in pedicle screw procedures. The recall involves specific lot numbers L561968 and L570545, with product code 7703-1600.
The recall was initiated because the Inserter does not contain a feature that locks the Rod in place during use. This design defect creates a potential for the Rod to disengage from the Inserter during insertion, which could lead to harm to the patient. The agency has classified this recall as Class II.
The affected units were distributed to Texas, Ohio, Nebraska, and New York. Healthcare facilities and consumers should stop using the affected devices and contact Biomet Spine, LLC for further instructions or replacement.
The recalled product
- Product
- Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a…
- Manufacturer
- Biomet Spine, LLC
- Affected units
- 10
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)
- LOT Numbers: L561968 and L570545 Product Code: 7703-1600
Distribution
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