STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12I
Summary
The FDA issued a Class II for STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STR by Ethicon, Inc.. Reason: Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility.
Details
Source
Device Recall
External ID
Z-1533-2024
Action Date
2024-04-24
Status
Ongoing
Category
device
Product Description
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
Lot/Code Info: UDI/GTIN: 30705031464289 (box) 10705031464285 (pouch) Lot Number: SHBAEC Exp. Date: June 30, 2024
Quantity Affected: 395 units
Reason for Recall
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
Distribution
CO GA IA MI NJ NY NY PA SC WI
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-08
Company
Raritan, 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 179 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-1533-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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