Exactech Recalls Gibralt Spine System Polyaxial Screws Due to Material Error
Exactech is recalling 242 Gibralt Spine System Polyaxial Screws because they contain springs made of type-304 stainless steel instead of the specified titanium alloy.
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 high-risk medical device with a material defect (incorrect alloy) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Exactech, Inc. is recalling 242 units of the Gibralt Spine System Polyaxial Screw. The recall was initiated because the products were identified to contain springs manufactured with type-304 stainless steel rather than the specified titanium alloy.
The affected products are distributed in the United States, including the states of Florida, New York, Oregon, Illinois, Pennsylvania, Missouri, and New Jersey. The recall covers specific sizes and lot numbers, including 3.5mm x 10mm, 3.5mm x 14mm, 3.5mm x 20mm, 3.5mm x 26mm, 4.0mm x 14mm, 4.0mm x 20mm, 4.0mm x 26mm, and various 1/4 Shank sizes.
The Gibralt Spine System is intended to promote fusion of the cervical and thoracic spine (C3-T3) for conditions such as degenerative disc disease, spondylolisthesis, and spinal stenosis. Patients who have received these implants should contact their healthcare provider for evaluation and guidance regarding the material discrepancy.
The recalled product
- Product
- Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and…
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 242
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 (20)
- size 3.5mm x 10mm
- Catalog #05-000-20-3510
- Lot Number #35917001. size 3.5mm x 14mm
- Catalog #05-000-20-3514
- Lot Number 35917002 and 40023002. size 3.5mm x 20mm
- Catalog #05-000-20-3520
- Lot Number 35917003. size 3.5mm x 26mm
- Catalog #05-000-20-3526
- Lot Number 35917004. size 4.0mm x 14mm
- Catalog #05-000-20-4014
- Lot Number 35917005. size 4.0mm x 20mm
- Catalog #05-000-20-4020
- Lot Number 35917006. size 4.0mm x 26mm
- Catalog #05-000-20-4026
- Lot Number 35917007. 1/4 Shank
- size 3.5mm x 26mm
- Lot Number 35917008. 1/4 Shank
- size 3.5mm x 30mm
- Catalog #05-000-20-3530
- Lot Number 35917009. 1/4 Shank
Distribution
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