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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Manufacturer
- Collagen Matrix Inc
- Hazard
- 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:
Related recalls
Same manufacturer · Collagen Matrix Inc
See all →- HighCollagen Dental Wound Dressing Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2022-10-05
- HighRESODURA Matrix Onlay Recalled Due to Unsealed Packaging
FDA (Devices) · 2022-03-02
- HighCollagen Dura Substitute Membrane Recalled for Compromised Sterility
FDA (Devices) · 2022-03-02
- ModerateCollagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions
FDA (Devices) · 2020-02-05
- ModerateCollagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions
FDA (Devices) · 2020-02-05
Same hazard · incorrect size
See all →- ModerateCobra EMG ET Tube Recalled Due to Incorrect Size Labeling
FDA (Devices) · 2024-09-04
- ModeratePICC Catheter Package Contains Wrong Length, Causing Procedural Delay
FDA (Devices) · 2024-08-21
- HighHip Prosthesis Component Mislabeled; Package Size May Not Match Device
FDA (Devices) · 2024-07-24
- HighSpinal fixation screws recalled due to incorrect size laser marking
FDA (Devices) · 2024-01-10
- ModerateMedComp Recalls Power Injectable CT Port Kits with Incorrect Port Size
FDA (Devices) · 2021-03-17
Similar recalls
- ModerateCollagen Matrix Recalls NuOss XC Sinus Dental Grafts for Shelf Life Failure
FDA (Devices) · 2016-03-23
- HighNuOss Collagen Blocks Recalled Due to Product Substitution Error
FDA (Devices) · 2022-03-30
- LowCollagen Matrix Recalls Neomem Membrane Due to Incorrect Packaging
FDA (Devices) · 2019-05-29
- ModerateCollagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions
FDA (Devices) · 2020-02-05
- HighBoston Scientific Recalls NephroMax Balloon Catheter Kits Due to Packaging Error
FDA (Devices) · 2013-07-17
- ModerateBaxter Recalls VERITAS Collagen Matrix Patches Due to Undersized Width
FDA (Devices) · 2021-01-20