a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membran
FDA device recall Z-1623-2012 · posted 2012-05-17 · Terminated
Recall details
- Recalling firm
- Kensey Nash Corp
- Reason for recall
- Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection,
- Action taken
- Reimser, Inc. sent an "URGENT PRODUCT RECALL-COLLAGUIDE COLLAGEN DENTAL MEMBRANE" letter dated March 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to cease use, secure and quarantine affect product. Additionally, a Recall Acknowledgement Form was attached for customers to complete and return to the firm via fax to 1-800-505-4982. Contact the firm at 484-713-2197 for questions regarding this recall.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- NPL
- Quantity affected
- total all sizes: 6387 units; p/n 20650-03 - 765 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2012-02-28
- Date posted
- 2012-05-17
- Date terminated
- 2013-04-11
- Location
- Exton, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE (K090919) | Kensey Nash Corp. | 2009-10-02 |