medical Class II Updated 2019-02-06

XTANT MEDICAL INC recalls Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF

Recalled Product

Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF X034-0242PC 26mm x 10mm x 12mm PLIF ASSY PC, REF X034-0243PC 26mm x 10mm x 6mm TLIF ASSY PC, REF X034-0280PC 28mm x 10mm x 7mm TLIF ASSY PC, REF X034-0281PC 28mm x 10mm x 8mm TLIF ASSY PC, REF X034-0282PC 28mm x 10mm x 9mm TLIF ASSY PC, REF X034-0283PC 28mm x 10mm x 10mm TLIF ASSY PC, REF X034-0284PC 28mm x 10mm x 11mm TLIF ASSY PC, REF X034-0285PC 28mm x 10mm x 12mm TLIF ASSY PC, REF X034-0286PC 28mm x 10mm x 13mm TLIF ASSY PC, REF X034-0287PC 28mm x 10mm x 14mm TLIF ASSY PC, REF X034-0288PC 28mm x 10mm x 15mm TLIF ASSY PC, REF X034-0289PC 28mm x 10mm x 16mm TLIF ASSY PC, REF X034-0290PC 26mm x 10mm x 6mm 5o PLIF Assy PC, REF X034-0387PC 26mm x 10mm x 7mm 5o PLIF Assy PC, REF X034-0388PC 26mm x 10mm x 8mm 5o PLIF Assy PC, REF X034-0389PC 26mm x 10mm x 9mm 5o PLIF Assy PC, REF X034-0390PC 26mm x 10mm x 10mm 5o PLIF Assy PC, REF X034-0391PC 26mm x 10mm x 11mm 5o PLIF Assy PC, REF X034-0392PC 26mm x 10mm x 12mm 5o PLIF Assy PC, REF X034-0393PC 26mm x 10mm x 13mm 5o PLIF Assy PC, REF X034-0394PC 26mm x 10mm x 14mm 5o PLIF Assy PC, REF X034-0395PC 26mm x 10mm x 15mm 5o PLIF Assy PC, REF X034-0396PC This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Hazard / Issue

This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration.

Issued by

FDA

Affected States: AZ, CA, CO, FL, IN, LA, MS, GA, MI, NV, WV, TX
Lot/Code Info: UPC/UDI/Lot numbers REF X034-0172PC, M697X0340172PC1 19211-2, 21017-1 REF X034-0173PC, M697X0340173PC1 041790, 17075-5, 17196-3 REF X034-0240PC, M697X0340240PC1 042050, 18890-1, 20745-1, 17196-12, 18216-1 REF X034-0241PC, M697X0340241PC1 039171, 042071, 054614, 056529, 057161, 058525, 17196-13, 20745-2 REF X034-0242PC, M697X0340242PC1 20962, 054621, 055442, 058526, 20745-3 REF X034-0243PC, M697X0340243PC1 042073, 054624, 058527, 16730-15, 17075-16, 17196-15,18216-4, 19212-4, 20745-4 REF X034-0280PC, M697X0340280PC1 043764, 062836, 063476, 065284, 040738PC, 19626-1, 19903-1, 20164-1, 20774-1 REF X034-0281PC, M697X0340281PC1 040746PC, 043852, 054531, 055202, 055436, 055742, 056756, 059809, 061983, 062837, 17304-2, 19903-2, 19212-7, 19626-2, 19891-1, 20164-2, 20774-2, 21269-2 REF X034-0282PC, M697X0340282PC1 040757PC, 043765, 054532, 054539, 055203, 055437, 055745, 056757, 059810, 062080, 062838, 063529, 19212-8, 19626-3, 19742-3 19903-1, 19903-3,20164-3, 20774-3, REF X034-0283PC, M697X0340283PC1 040759PC, 043853, 054370, 054540, 055204, 055438, 055746, 056758, 059811, 062081, 062839, 064312, 19212-9, 19626-4, 19742-4, 19903-4, 20462-3, 20774-4, 20164-4, 21269-3 REF X034-0284PC, M697X0340284PC1 040758PC, 043854, 054399, 054541, 055205, 055439, 055747, 056759, 059812, 062082, 19147-8A, 19903-5, 19212-10, 19626-5, 19742-5, 20164-5, 20462-4A REF X034-0285PC, M697X0340285PC1 040761PC, 043855, 054401, 055206, 054542, 055206, 055440, 055748, 056760, 059821, 19147-10, 19626-6, 20164-6 REF X034-0286PC, M697X0340286PC1 055441, 055749, 059822, 040809PC, 17304-7, 19212-12, 19626-7, 19742-7, 19903-7, 20164-7, 20462-5 REF X034-0287PC, M697X0340287PC1 040937PC, 19147-4, 19217-1, 19742-8, 20164-8, 20462-6 REF X034-0288PC, M697X0340288PC1 043856, 040810PC, 19147-5, 19147-5A, 19217-2, 19742-9, 19903-9 REF X034-0289PC, M697X0340289PC1 040938, 040938PC, 19147-6, 19217-3, 19147-6A, 19742-10, 20164-10 REF X034-0290PC, M697X0340290PC1 040745, 043859, 17304-11, 17304-11PC, 18574-7, 19147-11, 19147-11A, 19217-4, 19903-11, 20164-11 REF X034-0387PC, M697X0340387PC1 039775, 041928, 17075-4, 19217-5, 20745-5 REF X034-0388PC, M697X0340388PC1 055534, 061988, 18607-2, 19058, 20590-9, 20745-6 REF X034-0389PC, M697X0340389PC1 041929, 055443, 056752, 059802, 17075-18, 18861-8, 19217-6, 20745-7, 21273-2 REF X034-0390PC, M697X0340390PC1 054837, 055207, 055444, 055543, 055544, 056753, 059805, 063120, 19217-7, 18007-4, 18567-3, 20745-8 REF X034-0391PC, M697X0340391PC1 054403, 054626, 055208, 055446, 055544, 059806, 063121, 20745-9 REF X034-0392PC, M697X0340392PC1 054413, 054627, 055209, 055447, 055545, 056754, 063122, 17591-5, 18007-5, 18889-5, 18890-520590-10, 20745-10 REF X034-0393PC, M697X0340393PC1 038451, 038567, 054407, 054928, 055210, 055448, 055547, 056755, 20745-11, 21273-3 REF X034-0394PC, M697X0340394PC1 055211, 055449, 055548, 061987, 064315, 17756, 18007-6, 18890-6, 20590-5, 20745-12 REF X034-0395PC, M697X0340395PC1 16730-21, 19374-7, 17075-21, 20745-13, 21017-4 REF X034-0396PC, M697X0340396PC1 059807, 17591-6, 18890-7, 20745-14
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