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
630241936302419563024196630241976302419863024199630242016302420263024203630242046302420563024206
- Product00771300900
- Lots
62927082629270836302421063024211630242136302421463024215630242166302421763024218630242196302422063024221
- Product00771301000
- Lots62938997 63024226 63024227 63024228 63024229 63024230
- Product00771301100
- Lots
6288504062905574629984266302423463024235630242366302423763024238630242396302424063024241
- Product00771301200
- Lots
6292712363024256630242576302425863024259630242616302426263024263
- 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.
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