Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Summary
The FDA issued a Class II for Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR by Arthrex, Inc.. Reason: Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch..
Details
Source
Device Recall
External ID
Z-2107-2021
Action Date
2021-07-28
Status
Ongoing
Category
device
Product Description
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Lot/Code Info: Lots 12758314 and 13022357
Quantity Affected: 3985 pieces
Reason for Recall
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Distribution
US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-14
Company
Naples, FL
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 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Arthrex, Inc. has 80 FDA actions in our database, including 3 recalls and 77 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 (Arthrex, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Arthrex, Inc. have FDA actions?
Arthrex, Inc. has 80 FDA actions in our database, including 3 recalls and 77 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2107-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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