Ethicon, Inc. Recall 90016
Description: 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].
Ethicon, Inc. Recall 90016 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1053-2022 |
| Event ID | 90016 |
| Event Description | 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]. |
| Product Type | Devices |
| Distribution | International distribution in the country of China. |
| Quantity | 2808 (all OUS) |
| Recall Reason | Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up. |
| Device Classification | 20220518 |
| Device Code Info | Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049 |
| Center Classification Date | 20220510 |
| Recall Initiation Date | 20220324 |
| Recalling Firm | Ethicon, Inc. |
| Initial Notification | Letter |
| Similar To |