Z-0545-2015Class II
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on...
Instrumed International Inc dba Avalign German Specialty Instruments / initiated 2014-09-08 / Terminated
Instrumed International, Inc. began a recall of McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix... 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 FDA classified it as Class II and gives the reason as "The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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-0545-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Instrumed International Inc dba Avalign German Specialty Instruments
- Product
- McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names.
- Product code
- HBG Drills, Burrs, Trephines & Accessories (Manual)
- 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- The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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
- 4 McKenzie perforator drills
- 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: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: McKenzie Perforator Drill, 13 mm; Phoenix Instruments Item Number: 157-6043; Lot Number: 070412. 2) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Stealth Surgical; Stealth Surgical Product Name: McKenzie Perforator Drill, 13 mm; Stealth Surgical Item Number: SS2151; Lot Number: 070412. 3) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: CareFusion; CareFusion Product Name: McKenzie Perforator Drill, 13 mm; CareFusion Item Number: VM85-1235; Lot Number: 030211. 4) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: CareFusion; CareFusion Product Name: McKenzie Perforator Drill, 13 mm; CareFusion Item Number: VM85-1251; Lot Number: 050111. 5) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Boss Instruments; Boss Instruments Product Name: McKenzie Perforator Drill, 13 mm; Boss Instruments Item Number: 74-0140; Lot Number: 070412.
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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