XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 15 x 20 cm Rectangle Catalog #: 1161520
FDA device recall Z-1380-2011 · posted 2011-03-02 · Terminated
Recall details
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Reason for recall
- Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria.
- Action taken
- Davol issued recall notification to accounts by letter dated 1/06/11 requesting recalled units be returned. contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product to Davol. A fax sheet attached to the letter to be completed and fax to 1-401-825-8753.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FTM
- Quantity affected
- 1492 units
- Distribution
- Nationwide
- Date initiated
- 2011-01-07
- Date posted
- 2011-03-02
- Date terminated
- 2013-10-31
- Location
- Warwick, RI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PORCINE SURGICAL MESH; DERMAL MATRIX (K081272) | Brennen Medical, LLC | 2008-07-31 |