The Recall Desk
HighFDA (Devices)·Z-2583-2014·Announced 2014-09-10

Zimmer Recalls Natural-Knee Patella Bushings Due to Corrosion Complaints

Zimmer, Inc. is recalling Natural-Knee System Patella Bushings after receiving a trend of complaints indicating product corrosion. The affected orthopedic surgical instruments were distributed worldwide.

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 involves a medical device with a reported defect (corrosion) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Zimmer, Inc. is recalling the Natural-Knee System Patella Bushings, an orthopedic surgical instrument used to guide patella cuts during knee surgery. The recall was initiated after the company received a trend of complaints indicating corrosion of the product.

The affected units are identified by Part Number 6290-00-702 and include numerous specific lot numbers manufactured by both Zimmer and Centerpulse. The source text does not specify the total number of affected units, but notes that the products were distributed in the United States and in Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.

Healthcare providers and patients should stop using the affected patella bushings and contact Zimmer, Inc. for further instructions. The source text does not report any specific injuries or illnesses associated with the corrosion.

The recalled product

Product
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutt
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Surgical Instrument
Hazard
Affected units
8,638

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 Number: 6290-00-702. Lots Manufactured by Zimmer: 1324203
  • 1339203
  • 1346701
  • 1363348
  • 1373979
  • 1382208
  • 1385813
  • 1391253
  • 1421647
  • 1437118
  • 1440906
  • 1440943
  • 1451869
  • 1464915
  • 1469681
  • 1470531
  • 1472373
  • 1474483
  • 1538141
  • 1549267

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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