Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names:
FDA device recall Z-1777-2022 · posted 2022-09-23 · Open, Classified
Recall details
- Recalling firm
- Collagen Matrix Inc
- Reason for recall
- The packaging may not be sealed, which could compromise sterility.
- Action taken
- On August 3, 2022, Collagen Matrix began informing the distributors (initial consignees) to place the lot in question on ship hold. On August 8, 2022, Collagen Matrix began informing distributors by email to return the concerned products. Consignees are asked to return any recalled product to the recalling firm and complete the Certificate of Acknowledgement within 15 days of receipt and return it via email.
- Root cause
- Packaging change control
- Status
- Open, Classified
- Product code
- KGN
- Quantity affected
- 1336 units
- Distribution
- US distribution to distributors in IL, IN, MI, NC, OH, and TX
- Date initiated
- 2022-08-03
- Date posted
- 2022-09-23
- Location
- Oakland, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Collagen Dental Wound Dressings (K152600) | Collagen Matrix, Inc. | 2016-06-23 |