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.
Recall
- Recall Number
- Z-2138-2011
- Event Number
- 58449
- Firm
- Surgical Specialties Corp
- FEI Number
- 2522801
- Product Code
- DTH
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- March 30, 2011
- Posted
- May 4, 2011
- Terminated
- August 4, 2011
- Address
- 100 Dennis Dr, Reading, PA, 19606
Description
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.
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.
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.
Class 3 Recall - Worldwide Distribution-- USA and Australia.
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