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.
Reported: August 22, 2012 Initiated: July 13, 2012 #Z-2187-2012
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.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 24 to US Distributor with 7 further distributed
- Distribution
- Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zimmer, Inc.. Units affected: 24 to US Distributor with 7 further distributed.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 22, 2012. Severity: Moderate. Recall number: Z-2187-2012.
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