CLASS II ONGOING Device recall · Reported 30 Mar 2022 · FDA Enforcement Report
NuOss Collagen Block Size- used in filling periodontal recalled
Ace Surgical Supply is recalling NuOss Collagen Block Size- used in filling periodontal and maxillofacial defects, distributed nationwide in the US. The recall was initiated on 2 Feb 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0823-2022
- FDA event ID
- 89721
- Recalling firm
- Ace Surgical Supply, Brockton, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Feb 2022
- FDA classified
- 24 Mar 2022
- Reported
- 30 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 2 Feb 2022 | Recall initiated by company | |
| 24 Mar 2022 | Classified by FDA | +50 days |
| 30 Mar 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.
Questions about this recall
Why was it recalled?
NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
Which lots are affected?
Lot Number: BMBU21A1 Exp. Date: 2024-03-31 UDI: 00614950007264
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ace Surgical Supply
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Double Blade Shoe F/Unigraft Knife 1.5 Thick recalled | Ace Surgical Supply | Packaging Defects | CA, MI, OK |
| Drug | CLASS II | Succinylcholine 20 MG/ML INJ (Quelicin) Vials recalled | Ace Surgical Supply | Other | Nationwide |
| Device | CLASS II | Infinity Internal Hex Healing Abutment Platform CW- CH Straight recalled | Ace Surgical Supply | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |