Recall Z-0150-2023 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Ethicon, Inc.
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
| Date | Oct 31, 2022 (initiated Sep 20, 2022) |
| Status | Open, Classified |
| Reason | Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair |
| Root cause | Under Investigation by firm |
| Action | Ethicon notified the responsible Johnson & Johnson Affiliates in China who are contacting their impacted primary and secondary consignees and/or end customers. Translated letter dated 9/23/22. Customers are requested to return all unused impacted products that are in their inventory immediately. Returned products pertaining to this action will be segregated and destroyed by affiliates per local procedures and regulations |
| Quantity | 2,280 eaches |
| Distribution | International distribution of the country of China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151200 | STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device ETHICON, Inc., Aug 13, 2015 |