3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue
FDA device recall Z-0034-2009 · posted 2008-10-02 · Terminated
Recall details
- Recalling firm
- Surgical Specialties Corp
- Reason for recall
- mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture
- Action taken
- The recalling firm issued a Recall letter dated 9/9/08 to its customers. The letter informed the customers of the problem, the need to conduct a sub-recall, and return the product. Contact Surgical Specialties Corp. at 1-610-404-1000 for assistance.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- GAR
- Quantity affected
- 956 boxes
- Distribution
- USA--AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MD, MI, MS, NC, NJ, NY, OH, TN, TX, VA, and WA. OUS: Australia, Canada, and Fiji Islands.
- Date initiated
- 2008-09-09
- Date posted
- 2008-10-02
- Date terminated
- 2009-03-27
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES (K930825) | Surgical Specialties, Inc. | 1994-01-07 |