BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Summary
The FDA issued a Class II for BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. by Smith & Nephew Inc.. Reason: Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device..
Details
Source
Device Recall
External ID
Z-0581-2025
Action Date
2024-12-11
Status
Ongoing
Category
device
Product Description
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Lot/Code Info: Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.
Quantity Affected: 2,156 units
Reason for Recall
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Distribution
Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-29
Company
Andover, MA
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 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smith & Nephew Inc. has 78 FDA actions in our database, including 34 recalls and 44 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 (Smith & Nephew Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smith & Nephew Inc. have FDA actions?
Smith & Nephew Inc. has 78 FDA actions in our database, including 34 recalls and 44 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0581-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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