The Recall Desk
HighFDA (Devices)·Z-1376-2013·Announced 2013-06-05

Zimmer Recalls NEXGEN Complete Knee Solution Tibial Drills

Zimmer, Inc. is recalling 69 units of NEXGEN Complete Knee Solution Tibial Drills because the outside diameter may be oversized, preventing them from passing through the drill guide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (surgical instrument) where the defect could impede the procedure, but no injuries or illnesses are reported in the source text.

Plain-English summary

Zimmer, Inc. is initiating a lot-specific recall of 69 units of the NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. The product is used to prepare cylindrical holes in the native tibia during knee surgery. The affected units are identified by Part No. 00-5887-052-00 and lots 62181290 and 62183430.

The recall was initiated because the outside diameter of the drill may be oversized. This defect creates a potential for the drill to not pass through the applicable drill guide. The agency has classified this recall as Class II.

The affected products were distributed nationwide. Healthcare providers and facilities should check their inventory for the specific part and lot numbers listed above. If the product is found, it should be removed from use and returned to Zimmer, Inc. according to the company's instructions.

The recalled product

Product
NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
Manufacturer
Zimmer, Inc.
Affected units
69

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 No. 00-5887-052-00
  • lots 62181290 and 62183430

Distribution

Distributed nationwide across the United States.