Z-0989-2020 Class II Terminated
FDA device recall Z-0989-2020 was initiated by Ethicon, Inc. on January 3, 2020 and is designated Class II. 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. The recall status is terminated (terminated August 13, 2021). Affected quantity: 23688 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- January 3, 2020
- Termination Date
- August 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23688 units
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.
Distribution Pattern
Domestic distribution nationwide. US and Puerto Rico only.
Code Information
lot PGZ908