The Recall Desk
ModerateFDA (Devices)·Z-1096-2016·Announced 2016-03-23

Collagen Matrix Recalls NuOSS Cancellous Dental Product Due to Size Error

Collagen Matrix Inc is recalling 171 units of NuOSS Cancellous dental product shipped to Massachusetts because some units may have the incorrect size.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a size discrepancy without reporting any injuries, illnesses, or hospitalizations. This aligns with the rubric for moderate severity involving minor errors or low-risk issues where harm has not been reported.

Plain-English summary

Collagen Matrix Inc is recalling 171 units of NuOSS Cancellous, a product intended for use in dental surgery. The recall was initiated after the company discovered that one of the units shipped to a distributor may have included an incorrect size.

The affected product is identified by Reference No. BM2C20010-U and Lot no. BM2CU15E2. The distribution was limited to the state of Massachusetts. The recall was discovered on August 25, 2015.

Consumers and healthcare providers should check their inventory for the specific lot and reference numbers listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
NuOSS Cancellous Intended for use in dental surgery.
Affected units
171

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Reference No. BM2C20010-U Lot no. BM2CU15E2

Distribution

Distributed in 1 state: