Coated Vicryl (polyglactin 910) suture. Needle Type CTXB… recallZ-1087-06 · Ethicon, Inc. · initiated May 4, 2006
Terminated All recalls posted in June 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.
FDA root cause category: Other
What the company is doing
The firm sent out recall notification on 5/4/2006. The US consignees were sent a letter via return receipt.
Recall details
- Recall number
- Z-1087-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 4, 2006
- Posted by the FDA
- Jun 2, 2006
- Recalling firm
- Ethicon, Inc.
- Quantity
- 1157 dozens
- Product code
- GAM
- FDA submissions
- K022269
- Distribution
- Nationwide, Japan, Canada, and Taiwan.
Product description
Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide.
Code information (models, lots, serial numbers)
Product Codes/Product Lot Numbers-Expiration Dates: J774D/SB2371-01/2008; JB725/SB2416-01/2008; J864D/SB2426-01/2008.
Other devices under the same FDA submission
145 devices cleared under K022269 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Coated VICRYL J433HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID255 reports
- Coated VICRYL J570GEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID170 reports
- Coated VICRYL J258HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID155 reports
- VICRYL V960GEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall55 reports
- Coated VICRYL J494GEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID86 reports
- Coated VICRYL JB840Ethicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID81 reports
- Coated VICRYL J603HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID80 reports
- Coated VICRYL J602HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID76 reports
- VICRYL V449GEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID74 reports
- Coated VICRYL J311HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID71 reports
- Coated VICRYL J490GEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID67 reports
- Coated VICRYL J493GEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID63 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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