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 P
Summary
The FDA issued a Class II for STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: by Ethicon, Inc.. Reason: Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up..
Details
Source
Device Recall
External ID
Z-1053-2022
Action Date
2022-05-18
Status
Ongoing
Category
device
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].
Lot/Code Info: Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049
Quantity Affected: 2808 (all OUS)
Reason for Recall
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Distribution
International distribution in the country of China.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-24
Company
Somerville, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ethicon, Inc. has 23 FDA actions in our database, including 15 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ethicon, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ethicon, Inc. have FDA actions?
Ethicon, Inc. has 23 FDA actions in our database, including 15 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1053-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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