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].
Reported: May 18, 2022 Initiated: March 24, 2022 #Z-1053-2022
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.
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 2808 (all OUS)
- Distribution
- International distribution in the country of China.
- Location
- Somerville, NJ
Frequently Asked Questions
What product was recalled? ▼
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].. Recalled by Ethicon, Inc.. Units affected: 2808 (all OUS).
Why was this product recalled? ▼
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2022. Severity: Moderate. Recall number: Z-1053-2022.
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