Recall Z-0062-2015 ยท LXH Orthopedic Manual Surgical Instrument
Orthohelix Surgical Designs Inc
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.
| Date | Oct 10, 2014 (initiated Sep 19, 2014) |
| Status | Terminated |
| Reason | Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 38 |
| Distribution | USA Distribution -- in the states of WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, VA, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.