Z-1097-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 23, 2016
- Initiation Date
- May 13, 2013
- Termination Date
- June 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 347 units
Product Description
NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration
Reason for Recall
During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.
Distribution Pattern
US Distribution to state of: MA.
Code Information
Lot BMCXU11P1. BMCXU11H3 Lot BMCXU11P1, BMCXU12P1