Device product
3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
Z-2844-2016
Product summary
- Event
- Event 74928
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41
- Official record key
device-enforcement:Z-2844-2016
Official wording
Reason: OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
Code information: Product Number: 00-1050-3218 Lot Number: NM02346
Distribution pattern: Nationwide Distribution to AZ, CA, CO, DE, FL, GA, KY, MI, MN, MO, KY, RI, NY, OH, OR, RI, TN, TX, VA, WA Foreign: None VA/DOD: None
Derived failure modes
-
Labeling or packaging
mislabeled