X Spine Systems Recalls Calix P PEEK Lumbar System Trial Devices
X Spine Systems is recalling 1,504 Calix P PEEK Lumbar System trial devices because parts may detach and lodge in the surgical site.
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 the hazard involves a risk of harm (parts lodging in the surgical site) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
X Spine Systems Inc is recalling 1,504 units of the Calix P PEEK Lumbar System, PLIF Trial. The recall was initiated because the trials and rasps used to prepare the surgical site for implant placement may become detached from the inserter assembly part. If this occurs, the detached parts may become lodged in the intervertebral space.
The affected products were shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX, and WV. The products were also shipped to Australia, England, Germany, Italy, Mexico, Portugal, and the United Kingdom. The recall covers specific sizes and part numbers, including 22mm x 10mm and 26mm x 10mm variations, with various lot numbers listed in the agency documentation.
Healthcare providers and patients should contact X Spine Systems Inc for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- Calix P PEEK Lumbar System, PLIF Trial
- Manufacturer
- X Spine Systems Inc
- Affected units
- 1,504
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
- 22mm x 10mm x 6mm
- Part #:
- X034-0970
- Lot #:
- 015857-6-1
- 021425
- 025070
- 28221
- 31896
- 656802
- 22mm x 10mm x 7mm
- X034-0971
- 22mm x 10mm x 8mm
- X034-0972
- 015857-7-1
- 021426
- 025071
- 28224
- 656803
Distribution
Part of a larger recall action
This product is one of 4 recalled by X Spine Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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See all →- SevereX Spine Systems Recalls Calix T PEEK Lumbar System Trial Devices
FDA (Devices) · 2016-10-26
- HighX Spine Systems Recalls Calix P PEEK Lumbar System PLIF Rasps
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