Device product
The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.
Z-2187-2012
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 62499
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 to US Distributor with 7 further distributed
- Official record key
device-enforcement:Z-2187-2012
Official wording
Reason: Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws.
Code information: Part number 02.03155.026, lot 2649941
Distribution pattern: Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ.
Derived failure modes
-
Unknown
Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws.