Recall Z-0085-2013— Osteotech Inc
Class II · Terminated
Class II FDA medical device recall by Osteotech Inc, initiated 2012-04-20, terminated 2014-01-17. It names 4 FDA 510(k) clearances: K051188, K051195, K042707 and 1 more. Product: Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone.. Reason: Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised..
- Recalling firm
- Osteotech Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-04-20
- Terminated
- 2014-01-17
- Firm location
- Eatontown, NJ, United States
510(k) clearances named in this recall
4 on FDA's record- K051188 — GRAFTON DBM
- K051195 — GRAFTON DBM
- K042707 — GRAFTON PLUS DBM PASTE
- K043048 — GRAFTON PLUS DBM PASTE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone.
Reason for recall
Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
Data sourced from openFDA. This site is unofficial and independent of the FDA.