Z-0085-06

Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model...

Name: Z-0085-06 Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model...
Creator: Surgical Specialties Corp
Published: 2005-09-24
License: https://open.fda.gov/license/

Surgical Specialties Corp / initiated 2005-09-24 / Terminated / root cause: labeling and UDI

FDA source

Surgical Specialties Corp began a recall of Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes... on 2005-09-24. The reason FDA records is "mislabeled as double armed straight needle actually single armed straight needle". 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-0085-06
Status: Terminated
Initiated: 2005-09-24
Posted: 2005-10-21
Terminated: 2005-12-14
Recalling firm: Surgical Specialties Corp
Product: Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units.
Product code: GAR Suture, Nonabsorbable, Synthetic, Polyamide
Reason for recall: mislabeled as double armed straight needle actually single armed straight needle
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On 9/24/05, the recalling firm issued notifications to their customers via fax informing them of the problem and the need to return any remaining product to the recalling firm.
Quantity in commerce: 27 boxes
Distribution: The product was shipped to hospitals in IL, KY, NC, NE, OR, UT, and VA. The product was also shipped to distributors in FL, KY, PA, TN, and VA.
Product codes and lots: Lot number M732780

Product code GAR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)