3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
This recall has been terminated (originally issued October 2, 2008).
- Company
- Surgical Specialties Corp
- Recall Initiated
- September 9, 2008
- Posted
- October 2, 2008
- Terminated
- March 27, 2009
- Recall Number
- Z-0034-2009
- Quantity
- 956 boxes
- Firm Location
- Reading, PA
- Official Source
- View on FDA website ↗
Reason for Recall
mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture
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.
Lot / Code Info
Lot number M335870
Root Cause
Employee error
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.
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