Z-2746-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2020
- Initiation Date
- June 24, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 868
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.
Distribution Pattern
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
Code Information
Lot numbers 2038366, 2039311 and 2046505