M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product: 00771300500 Lots: 63006851 63006852 63024180 Product: 00771300600 Lots: 63024183 63024184 63024186 63024187 63024188 63024189 Product: 00771300700 Lots: 63024193 63024195 63024196 63024197 63024198 63024199 63024201 63024202 63024203 63024204 63024205 63024206 Product: 00771300900 Lots: 62927082 62927083 63024210 63024211 63024213 63024214 63024215 63024216 63024217 63024218 63024219 63024220 63024221 Product: 00771301000 Lots: 62938997 63024226 63024227 63024228 63024229 63024230 Product: 00771301100 Lots: 62885040 62905574 62998426 63024234 63024235 63024236 63024237 63024238 63024239 63024240 63024241 Product: 00771301200 Lots: 62927123 63024256 63024257 63024258 63024259 63024261 63024262 63024263 Product: 00771301300 Lots: 62885058 62939008 63024245 Product: 00784801400 Lot: 62924878 Product: 65771301100 Lot: 62939041
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer, Inc.
- Reason for Recall:
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe 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.
Product Codes/Lot Numbers:
Product: 00771300500 Lots: 63006851 63006852 63024180 Product: 00771300600 Lots: 63024183 63024184 63024186 63024187 63024188 63024189 Product: 00771300700 Lots: 63024193 63024195 63024196 63024197 63024198 63024199 63024201 63024202 63024203 63024204 63024205 63024206 Product: 00771300900 Lots: 62927082 62927083 63024210 63024211 63024213 63024214 63024215 63024216 63024217 63024218 63024219 63024220 63024221 Product: 00771301000 Lots: 62938997 63024226 63024227 63024228 63024229 63024230 Product: 00771301100 Lots: 62885040 62905574 62998426 63024234 63024235 63024236 63024237 63024238 63024239 63024240 63024241 Product: 00771301200 Lots: 62927123 63024256 63024257 63024258 63024259 63024261 63024262 63024263 Product: 00771301300 Lots: 62885058 62939008 63024245 Product: 00784801400 Lot: 62924878 Product: 65771301100 Lot: 62939041
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1699-2015
Related Recalls
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.