Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
Reported: February 12, 2020 Initiated: January 3, 2020 #Z-0989-2020
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.
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 23688 units
- Distribution
- Domestic distribution nationwide. US and Puerto Rico only.
- Location
- Somerville, NJ
Frequently Asked Questions
What product was recalled? ▼
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.. Recalled by Ethicon, Inc.. Units affected: 23688 units.
Why was this product recalled? ▼
Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2020. Severity: Moderate. Recall number: Z-0989-2020.
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