Z-1053-2022 Class II Ongoing
FDA device recall Z-1053-2022 was initiated by Ethicon, Inc. on Mar 24, 2022 and is designated Class II. Reason for recall: Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up. The recall status is ongoing. Affected quantity: 2808 (all OUS).
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- Mar 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2808 (all OUS)
Product 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].
Reason for Recall
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Distribution Pattern
International distribution in the country of China.
Code Information
Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1053-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026