Z-2187-2012 Class II Terminated
FDA device recall Z-2187-2012 was initiated by Zimmer, Inc. on Jul 13, 2012 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Sep 24, 2013). Affected quantity: 24 to US Distributor with 7 further distributed.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 22, 2012
- Initiation Date
- Jul 13, 2012
- Termination Date
- Sep 24, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 to US Distributor with 7 further distributed
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ.
Code Information
Part number 02.03155.026, lot 2649941
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2187-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026