NuOss Collagen Blocks Recalled Due to Product Substitution Error
Ace Surgical Supply is recalling NuOss Collagen Blocks because some units were mistakenly packaged with Collatene Fibrillar Collagen instead, which may result in suboptimal bone repair during dental and maxillofacial procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with product substitution error. No injuries or illnesses have been reported, but providing incorrect surgical material in bone-repair procedures constitutes a risk-of-harm scenario where patient harm has not yet been documented.
Plain-English summary
NuOss Collagen Block is a medical device used to fill bone defects in dental and maxillofacial procedures. The affected product (Catalog #5099250, Lot BMBU21A1, expiration March 31, 2024) consists of 31 units.
During packaging, these units were mistakenly filled with Collatene Fibrillar Collagen—a product designed for oral wound care—instead of the NuOss Collagen Block. While both are collagen-based products, they serve different clinical purposes. Using Collatene instead of NuOss may result in suboptimal bone repair during the intended periodontal or maxillofacial procedure.
The affected units were distributed worldwide, including the US states of Georgia, New York, Virginia, and Wisconsin, as well as France and Germany.
Healthcare providers and patients who may have been affected should contact Ace Surgical Supply Co., Inc. for guidance on the recalled product.
The recalled product
- Product
- NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
- Manufacturer
- Ace Surgical Supply Co., Inc.
- Hazard
- product-substitution
- compromised-efficacy
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)
- Lot Number: BMBU21A1 Exp. Date: 2024-03-31 UDI: 00614950007264
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighRayCare 2024A SP4 Oncology System Beam Set Delivery Note Data Loss
FDA (Devices) · 2026-07-08
- ModerateDuoGlide Short-Term Dialysis Catheter recall due to deficient manufacturing
FDA (Devices) · 2026-07-08
- HighRayCare 2024A SP1 Oncology Information System Software Recall
FDA (Devices) · 2026-07-08
- ModeratePower-Trialysis Slim-Cath Dialysis Catheters Recalled by Bard Access Systems
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA System patient circuits recalled for nebulizer leakage risk
FDA (Devices) · 2026-07-08