Device product
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
Z-0048-2020
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 83715
- Status
- Terminated
- Classification
- Class II
- Quantity
- 852 each
- Official record key
device-enforcement:Z-0048-2020
Official wording
Reason: The product does not meet certain internal strength testing specifications.
Code information: Lot # MMH401 GTIN: 10705031236042
Distribution pattern: States: IN MD AR IL GA TN NJ PA NC CA OK CO KS UT KY WA OH OR OUS: Australia Hong King India Japan Korea Singapore Thailand United States
Derived failure modes
-
Unknown
The product does not meet certain internal strength testing specifications.