Z-0540-2015Class II
Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's...
Instrumed International Inc dba Avalign German Specialty Instruments / initiated 2014-09-08 / Terminated
Instrumed International, Inc. began a recall of Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss... 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 FDA classified it as Class II and gives the reason as "The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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-0540-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Instrumed International Inc dba Avalign German Specialty Instruments
- Product
- Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion 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- The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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
- 8 Hudson braces
- 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: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Telelfex Medical; Telelfex Medical Product Name: Hudson Brace, snap lock chuck; Telelfex Medical Item Number: P-22880; Lot Number: 110212. 2) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Brace, snap lock chuck; Boss Instruments Item Number: 74-0121; Lot Number: 110212. 3) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Brace Only; Symmetry Surgical Item Number: 57-6004; Lot Number: 060414. 4) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Teleflex Medical; Teleflex Medical Product Name: Hudson Brace Only; Teleflex Medical Item Number: P-22881; Lot Number: 100211. 5) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: CareFusion; CareFusion Product Name: Hudson Brace Only; CareFusion Item Number: VM85-1233; Lot Number: 100211. 6) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Boss Instruments; v Product Name: Hudson Brace Only with Tumb Screw Lock; Boss Instruments Item Number: 74-0122; Lot Number: 100211.
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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