Captiva Lumbar Fusion Reamers Recalled for Detaching Color Rings
Captiva Spine is recalling 233 lumbar intervertebral fusion system reamers because the titanium color-coded rings may detach.
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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Captiva Spine, Inc. is recalling 233 units of its lumbar intervertebral fusion system reamers. The recall involves specific part numbers and lot numbers, including PI-0507 through PI-0514 and their corresponding -S variants.
The recall is being conducted because it is possible for the titanium color-coded ring to detach from the reamers. The affected devices were distributed to facilities in Georgia, Indiana, Florida, Utah, Arizona, California, and New York.
Healthcare providers should stop using the affected reamers and contact Captiva Spine for instructions on returning the devices. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
- Manufacturer
- Captiva Spine, Inc
- Hazard
- Affected units
- 233
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)
- Part #: PI-0507
- Lot #s:1308811A
- 1457704A
- Part #: PI-0508
- Lot #s: 1308812A
- 1457705A
- Part #: PI-0509
- Lot #s: 1038813A
- 1457706A
- Part #: PI-0510
- Lot #s: 1308814A
- 1457707A
- Part #: PI-0511
- Lot #s: 1308815A
- 1457708A
- Part #: PI-0512
- Lot #s: 1308816A
- 1457709A
- Part #: PI-0513
- Lot #s: 1308817A
Distribution
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