MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
Recall
- Recall Number
- Z-0062-2015
- Event Number
- 69294
- Firm
- Orthohelix Surgical Designs Inc
- FEI Number
- 3000718467
- Product Code
- LXH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- September 19, 2014
- Posted
- October 10, 2014
- Terminated
- October 31, 2016
- Address
- 1065 Medina Rd, Ste 500, Medina, OH, 44256-5376
Description
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
An Urgent - Medical Device Recall customer notification, dated September 19, 2014, was sent out via email and FEDEx to all distributors with instructions on returning the product. The letter identified the affected product and the reason for the recall. Customers are to immediately cease distribution of the affected product, and complete and return the questionnaire. The letter also states that the recalled product will be replaced. Questions are to be directed to the Customer Service Department 1-888-494-7950.
USA Distribution -- in the states of WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, VA, and PA.
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