Biomet Spine Cypher MIS Screw Inserter Recalled for Tip Failure
Ebi, LLC is recalling 32 units of the Biomet Spine Cypher MIS Screw Inserter due to an increased rate of instrument tip failure.
What this means for you
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 is classified as FDA Class II. The hazard involves a structural failure of a medical instrument used in spinal surgery, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Ebi, LLC is recalling 32 units of the Biomet Spine Cypher MIS Screw Inserter, Catalog number 14-501669. The recall involves Lot Number 006731. The product is an instrument used for the Spinal Screw Fixation System.
The recall is being conducted because the Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled units were distributed worldwide, including nationwide in the United States and in the Netherlands. The total quantity involved is 32 units, consisting of 30 domestic and 2 international units. Healthcare facilities and distributors should stop using the affected instruments and contact the recalling firm for further instructions.
The recalled product
- Product
- Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
- Manufacturer
- Ebi, Llc
- Hazard
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 (2)
- Catalog Number 14-501669
- Lot Number 006731
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Ebi, Llc
See all →- HighBiomet OrthoPak Bone Growth Stimulator System Recalled Due to Lead Wire Damage
FDA (Devices) · 2024-05-01
- HighReplacement Lead Wires Recalled for Risk of Treatment Delivery Failure
FDA (Devices) · 2024-05-01
- HighSpine Fusion Stimulator Recalled for Damaged Lead Wire Sheath
FDA (Devices) · 2024-05-01
- HighLead Wire Replacement Parts Recalled for Sheath Damage and Treatment Signal Loss
FDA (Devices) · 2024-05-01
- HighEbi Recalls Cypher MIS Screw System Due to Inoperative Screw Heads
FDA (Devices) · 2015-01-14
Same hazard · instrument failure
See all →- ModerateUniversal implant inserters recalled because the rotation tool handle can untread
FDA (Devices) · 2026-01-21
- ModerateSpinal instrument sets recalled because the rotation tool handle can untread
FDA (Devices) · 2026-01-21
- ModerateAchilles repair implant kits recalled over drill bits fusing during use
FDA (Food) · 2025-12-17
- HighAngled screwdrivers recalled after fusion system instruments failed in the field
FDA (Devices) · 2025-09-17
- HighAngled punch awls recalled following failure of fusion system instruments
FDA (Devices) · 2025-09-17