Z-2138-2011

SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. Intended for...

Name: Z-2138-2011 SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. Intended for...
Creator: Surgical Specialties Corp
Published: 2011-03-30
License: https://open.fda.gov/license/

Surgical Specialties Corp / initiated 2011-03-30 / Terminated / root cause: labeling and UDI

FDA source

Surgical Specialties Corp began a recall of SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. Intended for use in general soft tissue approximation and/or... on 2011-03-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2138-2011
Status: Terminated
Initiated: 2011-03-30
Posted: 2011-05-04
Terminated: 2011-08-04
Recalling firm: Surgical Specialties Corp
Product: 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.
Product code: DTH Suture, Cardiovascular
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.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: 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.
Quantity in commerce: 2,628
Distribution: Class 3 Recall - Worldwide Distribution-- USA and Australia.
Product codes and lots: Product Code - AC-0584D, lot number M446840

Product code DTH

K903029Class IISterile Black Monofilament Nylon Non-Absor. SutureLook, Inc. / cleared 1990-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)