Z-2276-2020Class II
Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) -
Genicon, Inc. / initiated 2018-08-21 / Open, Classified / root cause: manufacturing process
Genicon, Inc. began a recall of Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like... on . FDA classified it as Class II and gives the reason as "There is potential for the plastic optical tip to become detached from the metal shaft". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2276-2020
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Genicon, Inc.
- Product
- Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
- Product code
- GEA Cannula, Surgical, General & Plastic Surgery
- Reason for recall
- There is potential for the plastic optical tip to become detached from the metal shaft.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- A customer letter will be issued to impacted customers during the week of 5/25/2020. Customers are asked to inspect their inventory for impacted lots and return the devices to Genicon. Customers may contact Mr. Justin Colon, Genicon Customer Service on Mon-Thurs 9am-4pmEST at 407-657-4851, extension #800.
- Quantity in commerce
- 10 boxes (5 units per box)
- Distribution
- US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
- Product codes and lots
- Lot I8880-A
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2266-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2267-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2268-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2269-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2270-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2271-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2272-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2273-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2274-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2275-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2276-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2277-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2278-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2279-2020 | Class II | Ongoing | Voluntary: Firm initiated |
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