Recall Z-2146-2024 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Ethicon, Inc.
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H
| Date | Jun 14, 2024 (initiated May 10, 2024) |
| Status | Open, Classified |
| Reason | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| Root cause | Under Investigation by firm |
| Action | Erhicon issued Urgent: Medical Device Recall (Removal) letter on May 10, 2024 to US Distributors, primary and secondary consignees via UPS second day. Ethicon Johnson & Johnson affiliates in EMEA, LATAM, APAC and Canada will be contacting all their impacted primary and secondary consignees and/or end customers. Letter states reason for recall, health risk and action to take: 1. Determine whether you have inventory of the lots listed in Attachment 1. If so, you may " Option 1: Remove the first package of suture from a complete box, i. Quarantine and return it for credit. You may use the remaini |
| Quantity | 56952 units |
| Distribution | Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable S ETHICON, Inc., Jun 27, 2019 |