Recall Z-0989-2020— Ethicon, Inc.
Class II · Terminated
Class II FDA medical device recall by Ethicon, Inc., initiated 2020-01-03, terminated 2021-08-13. It names one FDA 510(k) clearance: K022269. Product: Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.. Reason: Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point..
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-03
- Terminated
- 2021-08-13
- Firm location
- Somerville, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
Reason for recall
Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
Data sourced from openFDA. This site is unofficial and independent of the FDA.