Device product
STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
Z-0047-2020
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 83715
- Status
- Terminated
- Classification
- Class II
- Quantity
- 416 each
- Official record key
device-enforcement:Z-0047-2020
Official wording
Reason: The product does not meet certain internal strength testing specifications.
Code information: Lot # LPH946 GTIN: 10705031235823
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.