Collagen Matrix Inc: Medical Device Recall in 2016 - (Recall #: Z-1097-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: May 13, 2013

Date Posted: March 23, 2016

Recall Number: Z-1097-2016

Event ID: 73206

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.

Status: Terminated

Product Quantity: 347 units

Code Information:

Lot BMCXU11P1. BMCXU11H3 Lot BMCXU11P1, BMCXU12P1

Distribution Pattern:

US Distribution to state of: MA.

Voluntary or Mandated:

Voluntary: Firm initiated