The Recall Desk
SevereFDA (Devices)·Z-2091-2012·Announced 2012-08-08

Zimmer Recalls Nextgen Knee Instruments Due to Spring Clip Fracture Risk

Zimmer Inc. is recalling 1,662 Nextgen Complete Knee Solution Femoral and Provisional Impactor/Extractor instruments because the spring clip may fracture or fall off during use, potentially leaving fragments in the surgical site.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of device fragments being left in the surgical site, which aligns with the rubric criteria for significant injury or structural defects.

Plain-English summary

Zimmer Inc. is recalling 1,662 units of the Nextgen Complete Knee Solution Femoral and Provisional Impactor/Extractor, REF 00-5901-026-00, Non-Sterile. The affected instruments are distributed worldwide, including in the United States, Singapore, China, Hong Kong, Canada, Australia, Japan, Europe, Germany, India, and Finland.

The recall is due to a design issue with the spring clip for the jaw assembly. Although the design was updated in March 2011 to address previous fractures, Zimmer has received complaints that the spring clip may fracture or fall off the instrument during use. If this occurs, a device fragment may be left in the surgical site.

Healthcare providers should stop using the affected instruments and contact Zimmer Inc. for further instructions. The specific lot numbers affected are listed in the agency's recall record.

The recalled product

Product
Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Manufacturer
Zimmer Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
1,662

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 (20)

  • Part 00-5901-026-00 Lot 11002148
  • 11002149
  • 11002791
  • 11002792
  • 11002831
  • 11003439
  • 11003449
  • 61800676
  • 61814993
  • 61909414
  • 61924920
  • 61980656
  • 61985378
  • 61988272
  • 61990656
  • 62003795
  • 62011220
  • 77000065
  • 77000573
  • 77000574

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Zimmer Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same hazard · device fragment

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