Device product
SUTUREFIX ULTRA Suture, Product number 72203855
Z-2746-2020
Product summary
- Event
- Event 85981
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 868
- Official record key
device-enforcement:Z-2746-2020
Official wording
Reason: 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.
Code information: Lot numbers 2038366, 2039311 and 2046505
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
Derived failure modes
-
Labeling or packaging
packaging error