Reported Jun 17, 2015 · Terminated

M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product…

Zimmer, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304

Is this the product you have?

  • M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented
  • acetabular component) Product UsageUsage:
  • Total hip replacement for the followingsevere hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures
Lot codes and dates
  • Product00771300500
  • Lots63006851 63006852 63024180
  • Product00771300600
  • Lots63024183 63024184 63024186 63024187 63024188 63024189
  • Product00771300700
  • Lots
    • 63024193
    • 63024195
    • 63024196
    • 63024197
    • 63024198
    • 63024199
    • 63024201
    • 63024202
    • 63024203
    • 63024204
    • 63024205
    • 63024206
  • Product00771300900
  • Lots
    • 62927082
    • 62927083
    • 63024210
    • 63024211
    • 63024213
    • 63024214
    • 63024215
    • 63024216
    • 63024217
    • 63024218
    • 63024219
    • 63024220
    • 63024221
  • Product00771301000
  • Lots62938997 63024226 63024227 63024228 63024229 63024230
  • Product00771301100
  • Lots
    • 62885040
    • 62905574
    • 62998426
    • 63024234
    • 63024235
    • 63024236
    • 63024237
    • 63024238
    • 63024239
    • 63024240
    • 63024241
  • Product00771301200
  • Lots
    • 62927123
    • 63024256
    • 63024257
    • 63024258
    • 63024259
    • 63024261
    • 63024262
    • 63024263
  • Product00771301300
  • Lots62885058 62939008 63024245
  • Product00784801400
  • Lot62924878
  • Product65771301100
  • Lot62939041
Amount recalled
752

Where it was sold

Why it was recalled

Stop using this product now

Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv¿ femoral stems and modular necks due higher than allowed cytotoxicity levels found with the product. Reasonable probability of adverse biological response and subsequent revision

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 2, 2016 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.