Device product
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.
Z-0062-2015
Product summary
- Event
- Event 69294
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38
- Official record key
device-enforcement:Z-0062-2015
Official wording
Reason: Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
Code information: Part Number: MFT-074-CC-24; Lot: 3164011
Distribution pattern: USA Distribution -- in the states of WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, VA, and PA.
Derived failure modes
-
Unknown
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer