Z-0535-2015Class II
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate...
Instrumed International Inc dba Avalign German Specialty Instruments / initiated 2014-09-08 / Terminated
Instrumed International, Inc. began a recall of A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry... on . FDA classified it as Class II and gives the reason as "The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0535-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Instrumed International Inc dba Avalign German Specialty Instruments
- Product
- A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.
- Product code
- DRC Trocar
- Reason for recall
- The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
- FDA root cause
- No Marketing Application
- Action
- Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
- Quantity in commerce
- 11 trocars
- Distribution
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Product codes and lots
- 1) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm; Instrumed Product Number: 500-01938; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, lg, 12 mm; Symmetry Surgical Item Number: 54-7004; Lot Numbers: 050213, 100410. 2) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm; Instrumed Product Number: 500-01938; Trade Name: CareFusion; CareFusion Product Name: Nelson Patterson Trocar, lg, 12 mm; CareFusion Item Number: VM72-3111; Lot Number: 050213. 3) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Instrumed Product Number: 500-01943; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Symmetry Surgical Item Number: 54-7005; Lot Number: 060312. 4) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Instrumed Product Number: 500-01943; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Ambler Surgical Item Number: 95-203; Lot Number: 100410. 5) Instrumed Product Name: Nelson Patterson Trocar, med, 1.5 mm; Instrumed Product Number: 500-01948; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, med, 1.5 mm; Symmetry Surgical Item Number: 54-7006; Lot Number: 100410. 6) Instrumed Product Name: Nelson Patterson Trocar, sm, 6.0 mm; Instrumed Product Number: 500-01953; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, sm, 6.0 mm; Symmetry Surgical Item Number: 54-7007; Lot Number: 030312.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0532-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0533-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0534-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0535-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0536-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0537-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0538-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0539-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0540-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0541-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0542-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0543-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0544-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0545-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0546-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0547-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0548-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0549-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0550-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0551-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0552-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0553-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0554-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0555-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0556-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0557-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0558-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0559-2015 | Class II | Terminated | Voluntary: Firm initiated |
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