Summary
The FDA issued a Class II for Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068 by K2M, Inc. Reason: Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cav.
Details
Source
Device Recall
External ID
Z-0104-2022
Action Date
2021-10-20
Status
Terminated
Category
device
Product Description
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Lot/Code Info: Lots CCUNA, HYMJ, KNCU
Quantity Affected: 23
Reason for Recall
Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.
Distribution
Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-08
Company
Leesburg, VA
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 174 device recalls issued in the same week, part of 403 device-related FDA actions this month.
K2M, Inc has 8 FDA actions in our database, including 4 recalls and 4 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 (K2M, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does K2M, Inc have FDA actions?
K2M, Inc has 8 FDA actions in our database, including 4 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0104-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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