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