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.
FDA Recall Z-0034-2009 · Posted 2008-10-02
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Recalling FirmSurgical Specialties Corp
Recall StatusTerminated
Product CodeGAR
Date Initiated2008-09-09
Date Terminated2009-03-27
Product Quantity956 boxes
Reason for Recall
mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture
Firm Action
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
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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