Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 0
Summary
The FDA issued a Class II for Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Ar by Medagent Inc. Reason: Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is tra.
Details
Source
Device Recall
External ID
Z-1184-2024
Action Date
2024-03-06
Status
Ongoing
Category
device
Product Description
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.
Lot/Code Info: Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673
Quantity Affected: 84 units
Reason for Recall
Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.
Distribution
TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-21
Company
Portsmouth, NH
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 205 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Medagent Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medagent Inc have FDA actions?
This is the only FDA action we have on record for Medagent Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1184-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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