The Recall Desk
ModerateFDA (Devices)·Z-2187-2012·Announced 2012-08-22

Zimmer Recalls NCB Polyaxial Locking Plate System NCB Screws Due to Incorrect Size

Zimmer, Inc. is recalling 26mm NCB Polyaxial Locking Plate System screws because a lot contained incorrect 32mm screws.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Zimmer, Inc. is recalling the NCB Polyaxial Locking Plate System NCB screws, 26mm (part number 02.03155.026, lot 2649941). These non-sterile implantable screws are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, intended for bicortical anchorage.

The recall was initiated after a Zimmer investigation following a complaint found that one lot of the 26mm screws distributed in the United States contained incorrect 32mm screws. The affected units were distributed nationwide, including in the states of Arizona, Illinois, Indiana, Maine, and New Jersey. A total of 24 units were sent to a US Distributor, with 7 further distributed.

Healthcare providers and facilities should check their inventory for the specific part number and lot number listed above. If the product is found, it should be removed from use and returned to the manufacturer or the distributor in accordance with their instructions.

The recalled product

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.
Manufacturer
Zimmer, Inc.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Part number 02.03155.026
  • lot 2649941

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically: