DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate posto
Summary
The FDA issued a Class II for DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fix by DePuy Mitek, Inc., a Johnson & Johnson Co.. Reason: IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip t.
Details
Source
Device Recall
External ID
Z-1680-2023
Action Date
2023-06-14
Status
Ongoing
Category
device
Product Description
DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
Lot/Code Info: UDI-DI: 10886705002085 All lot numbers
Quantity Affected: 3328 units
Reason for Recall
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Switzerland, China, Czech Republic, Germany, Egypt, Spain, United Kingdom, Hong Kong, Hungary, Ireland, India, Italy, Korea, Netherlands, New Zealand, Slovakia, Thailand.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-13
Company
Norwood, 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 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DePuy Mitek, Inc., a Johnson & Johnson Co. has 7 FDA actions in our database, including 7 recalls.
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 (DePuy Mitek, Inc., a Johnson & Johnson Co.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DePuy Mitek, Inc., a Johnson & Johnson Co. have FDA actions?
DePuy Mitek, Inc., a Johnson & Johnson Co. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1680-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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