Recall Z-1053-2022 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Ethicon, Inc.
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
| Date | Mar 24, 2022 |
| Status | Open, Classified |
| Reason | Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up. |
| Root cause | Employee error |
| Action | A translated notification letter was mailed to customers in China on 03/24/2022. Customers are advised to no longer use or distribute recalled product. Arrange returns through your upstream distributor or Johnson & Johnson Medical (Shanghai) Ltd. All customers and sub-distributors are to complete and submit the acknowledgement form. Contact your local sales representative with questions or contact 1-877-ETHICON. |
| Quantity | 2808 (all OUS) |
| Distribution | International distribution in the country of China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122898 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corp. Dba Angiotech, Oct 22, 2012 |