Device product
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
Z-0989-2020
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 84639
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23688 units
- Official record key
device-enforcement:Z-0989-2020
Official wording
Reason: Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
Code information: lot PGZ908
Distribution pattern: Domestic distribution nationwide. US and Puerto Rico only.
Derived failure modes
-
Unknown
Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.