SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, opthalmic, and neurological procedures.
- Company
- Surgical Specialties Corp
- Recall Initiated
- March 30, 2011
- Posted
- May 4, 2011
- Terminated
- August 4, 2011
- Recall Number
- Z-2138-2011
- Quantity
- 2,628
- Firm Location
- Reading, PA
Reason for Recall
Mislabeled - a number of units of the product labeled as 4-0 Black Mono Nylon suture product contain a 4-0 Black Braided Silk suture.
Distribution
Class 3 Recall - Worldwide Distribution-- USA and Australia.
Lot / Code Info
Product Code - AC-0584D, lot number M446840
Root Cause
Mixed-up of materials/components
Action Taken
Surgical Specialites sent an Urgent Product Recall Notification letter on March 30, 2011, along with an attached Customer Acknowledgment Form to the affected consignees. It was reported that upon opening a box labeled as 4.0 Black Mono Nylon, it was observed that the package acutally contained 4-0 Black Braided Silk suture. Customers were to review their current inventory, segregate the affected lot number and / or contact their customer accounts that have purchased this specific item / lot code requesting a return of the product to customers' facility. To ensure customers have received this notification and to arrange for credit and the return of identified product, the Customer Acknowledgment Form should be completed and returned via fax to our Quality Assurance department at (610) 404-8488.