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Recall Observatory FDA recall evidence

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

July 13, 2012

Class II

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

    reason.no_named_rule · v1.0.0

    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.