Theken Spine Llc

The products are identified with the following Model Numbers and Trade Names:   FormPutty - Model #50-07-0050 FormPutty - Model #-50-07-0100 SBvFShape - Model #-725-7010 SBvFShape - Model #-725-7025 SBvFShape - Model #-725-7050 SBvF Shape - Model #-725-7100 SynFlow - Model #-05-7100-010 SynFlow - Model #-05-7100-025 SynFlow - Model #-05-7100- 050 SynFlow - Model #-05-7100-100 TheriGraft TCP Putty - Model #107010 TheriGraft TCP Putty - Model #107025  TheriGraft TCP Putty - Model #107050 TheriGraft TCP Putty - Model #107100 Valeo BP - Model #817010 Valeo BP - Model #817025 Valeo BP - Model #817050 Valeo B - Model #817100 X-Putty - Model #TS0005 X-Putty - Model #TS0006  The product are also identified with the following Lot Numbers and Expiration Dates: A09I02XY - Expiration Date: 2011-09; A09I03XY - Expiration Date: 2011-09; A09I04XY - Expiration Date: 2011-09; A09K01XY - Expiration Date: 2011-11; A09L01XY - Expiration Date: 2011-12; A10A01XY, Expiration Date: 2012-01; and A10C04XY - Expiration Date: 2012-03. Please Note: XY denotes a 'letter number' combination that specified the size and packaging sequence for the specific unit(s).

Orthopedic Devices

3

Yes

Nationwide Distribution - including UT, SD, TX, AL, PA, CA, MI, OH, NJ, NH, MD, ID, FL, LA, NM, TN, IA, and OR.

Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different names. They are: Form-Putty; SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow. || The product is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and are intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The products are intended for use in defects of the skeletal system (i. e. the extremities, spine and pelvis).

A total of 136 Catalog Numbers of the suspect device were affected by the firm's corrective action. They are as follows:   22-10-0118 22-10-0366 22-12-4016 22-17-4515 22-20-0351 22-21-4017 22-10-0120 22-10-0369 22-12-4018 22-17-4517 22-20-0354 22-21-4018 22-10-0122 22-10-0372 22-13-4513 22-18-4513 22-20-0357 22-22-4511 22-10-0124 22-10-0375 22-13-4515 22-18-4515 22-20-0360 22-22-4513 22-10-0126 22-10-0468 22-13-4517 22-18-4517 22-20-0363 22-22-4515 22-10-0128 22-10-0472 22-14-4513 22-20-0118 22-20-0366 22-22-4517 22-10-0130 22-10-0476 22-14-4515 22-20-0120 22-20-0369 22-22-4519 22-10-0132 22-10-0480 22-14-4517 22-20-0122 22-20-0372 22-23-4010 22-10-0134 22-10-0484 22-15-4010 22-20-0124 22-20-0375 22-23-4011 22-10-0231 22-10-0488 22-15-4012 22-20-0126 22-20-0468 22-23-4012 22-10-0234 22-10-0492 22-15-4013 22-20-0128 22-20-0472 22-23-4013 22-10-0237 22-11-4010 22-15-4014 22-20-0130 22-20-0476 22-23-4014 22-10-0240 22-11-4012 22-15-4015 22-20-0132 22-20-0480 22-23-4015 22-10-0243 22-11-4013 22-15-4016 22-20-0134 22-20-0484 22-23-4016 22-10-0246 22-11-4014 22-15-4018 22-20-0231 22-20-0488 22-23-4017 22-10-0249 22-11-4015 22-16-4010 22-20-0234 22-20-0492 22-23-4018 22-10-0252 22-11-4016 22-16-4012 22-20-0237 22-21-4010 22-24-4511 22-10-0348 22-11-4018 22-16-4013 22-20-0240 22-21-4011 22-24-4513 22-10-0351 22-12-4010 22-16-4014 22-20-0243 22-21-4012 22-24-4515 22-10-0354 22-12-4012 22-16-4015 22-20-0246 22-21-4013 22-24-4517 22-10-0357 22-12-4013 22-16-4016 22-20-0249 22-21-4014 22-24-4519 22-10-0360 22-12-4014 22-16-4018 22-20-0252 22-21-4015  22-10-0363 22-12-4015 22-17-4513 22-20-0348 22-21-4016

Orthopedic Devices

2

Yes

Nationwide Distribution - USA including AL, AZ, CA, CT, FL, GA, HI, IL, ID, IN, KS, LA, MI, MD, MN, MA, MD, MS, NE, NY, NC, NJ, NV, NM, OH, OR, OK, PA, TN, TX, UT, WI, and WA.WA.

Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1. || Manta Ray Anterior Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion.