| Class 2 Device Recall CareFusion, Boss Instruments | |
Date Initiated by Firm | September 08, 2014 |
Date Posted | December 16, 2014 |
Recall Status1 |
Terminated 3 on November 29, 2017 |
Recall Number | Z-0557-2015 |
Recall Event ID |
69471 |
Product Classification |
Drills, burrs, trephines & accessories (manual) - Product Code HBG
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Product | Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names. |
Code Information |
1) Instrumed Product Name: Cloward Spanner Gauge, Small 5 1/8"; Instrumed Product Number: 650-11864; Trade Name: Boss Instruments; Boss Instruments Product Name: Cloward Spanner Gauge, Small 5 1/8"; Boss Instruments Item Number: 74-1448; Lot Number: 070412. 2) Instrumed Product Name: Cloward Spanner Gauge, Small 5 1/8"; Instrumed Product Number: 650-11864; Trade Name: CareFusion; CareFusion Product Name: Cloward Spanner Gauge, Small 5 1/8"; CareFusion Item Number: VM85-2559; Lot Number: 070412. 3) Instrumed Product Name: Cloward Spanner Gauge, Large 5 1/8"; Instrumed Product Number: 650-11869; Trade Name: Boss Instruments; Boss Instruments Product Name: Cloward Spanner Gauge, Large 5 1/8"; Boss Instruments Item Number: 74-1449; Lot Number: 070412. |
Recalling Firm/ Manufacturer |
Instrumed International, Inc. 626 Cooper Ct Schaumburg IL 60173-4537
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For Additional Information Contact | Ms. Jennifer S. Staunton 847-908-6119 |
Manufacturer Reason for Recall | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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 Determined Cause 2 | 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 | 5 Cloward Spanner gauges |
Distribution | Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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