Collagen Matrix Recalls NuOss XC Sinus Dental Grafts for Shelf Life Failure
Collagen Matrix Inc is recalling 347 units of NuOss XC Sinus dental grafts distributed in Massachusetts because some products failed to expand properly during shelf life testing.
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 functional failure in shelf life testing without reporting any patient injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Collagen Matrix Inc is voluntarily recalling 347 units of NuOss XC Sinus dental grafts, specifically Reference No 509-3001 (BMCU17) and Reference No 509-3002 (BMCU22). The affected lots are BMCXU11P1, BMCXU11H3, and BMCXU12P1. These products were distributed in the United States to the state of Massachusetts by ACE Surgical Supply Co, Inc.
The recall was initiated after 36-month real-time shelf life testing revealed that 3 of 13 products did not pass the recovery test. This test requires the compressed product to fully expand within one minute of hydration time. The failure indicates that the device may not perform as intended during dental surgery procedures such as sinus floor elevation or bone grafting.
Healthcare providers and patients who have used or possess these specific lots should contact Collagen Matrix Inc or their distributor for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- 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 -augme
- Manufacturer
- Collagen Matrix Inc
- Category
- Medical Device — Dental Grafts
- Hazard
- Affected units
- 347
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 (2)
- Lot BMCXU11P1. BMCXU11H3 Lot BMCXU11P1
- BMCXU12P1
Distribution
Distributed in 1 state:
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