Reported Oct 26, 2016 · Terminated
Calix P PEEK Lumbar System, PLIF Trial
X Spine Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: X Spine Systems Inc · 452 Alexandersville Rd · Miamisburg, OH · 45342-3658
Is this the product you have?
- Calix P PEEK Lumbar System, PLIF Trial
- Lot codes and dates
18 of 18 products
Products covered by this recall # Product as published 1 Size, 22mm x 10mm x 6mm, Part #:, X034-0970, Lot #:, 015857-6-1, 021425, 025070, 28221, 31896, 656802 2 Size, 22mm x 10mm x 7mm, Part #:, X034-0971, Lot #:, 015857-6-1, 021425, 025070, 28221, 31896, 656802 3 Size, 22mm x 10mm x 8mm, Part #:, X034-0972, Lot #:, 015857-7-1, 021426, 025071, 28224, 656803 4 Size, 22mm x 10mm x 9mm, Part #:, X034-0973, Lot #:, 015857-8-1, 021427, 025072, 28225, 28225R, 656804 5 Size, 22mm x 10mm x 10mm , Part #:, X034-0974, Lot #:, 015857-9-1, 021428, 025073, 28226, 656805 6 Size, 22mm x 10mm x 11mm, Part #:, X034-0975, Lot #:, 015857-10-1, 021429, 025074, 28227, 656806 7 Size, 22mm x 10mm x 12mm, Part #:, X034-0976, Lot #:, 015857-11-1, 021430, 025075, 28228, 656807 8 Size, 22mm x 10mm x 13mm, Part #:, X034-0977, Lot #:, 015857-12-1, 021432, 025076, 28229, 656808 9 Size, 22mm x 10mm x 14mm, Part #:, X034-0978, Lot #:, 015857-13-1,021433, 025077,125077, 28230, 656809 10 Size, 22mm x 10mm x 15mm, Part #:, X034-0979, Lot #:, 656810, 015857-13, 21434, 25078, 28231 11 Size, 22mm x 10mm x 16mm, Part #:, X034-0980, Lot #:, 015857-15-1, 015857-16-1, 021435, 021436, 025079, 28232, 656811 12 Size, 26mm x 10mm x 6mm, Part #:, X034-1050, Lot #:, 015857-15-1, 015857-16-1, 021435, 021436, 025079, 28232, 656811 13 Size, 26mm x 10mm x 8mm, Part #:, X034-1052, Lot #:, 015857-19-1, 021439, 025081, 10346, 26234, 28234, 656813, 656813R 14 Size, 26mm x 10mm x 9mm, Part #:, X034-1053, Lot #:, 10121, 11947 15 Size, 26mm x 10mm x 10mm, Part #:, X034-1054, Lot #:, 015857-20-1, 021440, 025082, 28235, 656814 16 Size, 26mm x 10mm x 11mm, Part #:, X034-1055, Lot #:, 10124, 11948 17 Size, 26mm x 10mm x 12mm, Part #:, X034-1056, Lot #:, 015857-21-1, 021441, 025083, 28236, 656815 18 Size, 26mm x 10mm x 13mm, Part #:, X034-1057, Lot #:, 10125, 11949 & Size, 26mm x 10mm x 14mm, Part #:, X034-1058, Lot #:, 021443, 015857-22-1, 015857-23-1, 021442, 021443, 025084, 28237, 656816. - Amount recalled
- 1504 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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