Device product
CUSTOM SUTURE PACK; Item Number: US1540 and US1614
Z-2547-2017
Product summary
- Firm
- Medtronic
- Event
- Event 77144
- Status
- Terminated
- Classification
- Class II
- Quantity
- 478,465 (total for all products)
- Official record key
device-enforcement:Z-2547-2017
Official wording
Reason: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Code information: A5C1345X A5E0919X
Distribution pattern: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
Derived failure modes
-
Labeling or packaging
incomplete seal