PlainRecalls
FDA Devices Moderate Class II Ongoing

SUTUREFIX ULTRA Suture, Product number 72203855

Reported: August 12, 2020 Initiated: June 24, 2020 #Z-2746-2020

Product Description

SUTUREFIX ULTRA Suture, Product number 72203855

Reason for Recall

A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
868
Distribution
Domestic distribution to AL AR AZ CO GA IL IN KS KY MD MN MO NC NE NJ NY OK PA PR TN TX VA WI. Foreign distribution to Australia Austria Belgium Finland France Germany Great Britain Ireland Italy Japan Luxembourg Mexico Netherlands Poland Portugal Singapore South Africa Spain Sweden Switzerland
Location
Andover, MA

Frequently Asked Questions

What product was recalled?
SUTUREFIX ULTRA Suture, Product number 72203855. Recalled by Smith & Nephew, Inc.. Units affected: 868.
Why was this product recalled?
A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 12, 2020. Severity: Moderate. Recall number: Z-2746-2020.