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FDA Recall Issued: Zimmer M/L Taper Hip Prosthesis

Hip problems

On June 8, 2015, the U.S. Food and Drug Administration (FDA) issued a Class I recall of the Zimmer M/L Taper with Kinective Technology Femoral Stems and Necks. The devices involved were manufactured and distributed from March 31, 2015 through April 20, 2015.

The recall, based on a May 18, 2015 Zimmer-issued recall notification letter, is due to “higher than expected” manufacturing residues being left on the devices.

The Zimmer device allows surgeons to fit the implant specifically to the patient. During hip replacement surgery, the damaged portions of the hip joint are removed and replaced with an integrated system of products, which includes the femoral stem and neck


Potential Adverse Reactions

These residues can cause serious health issues including:

  • Allergic reaction
  • Pain
  • Infections
  • Death

Revision surgery may be required to replace the affected implant. These surgeries can be more dangerous than the initial surgery and can further damage the area of the implant. Talk to your doctor to understand the potential risks and recovery needs for your situation.


FDA Class I Recall of Zimmer Products

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The specific Zimmer product part numbers, lot numbers and descriptions include:

Part Number Lot Number Item Description
00771301300 62885058 MOD ML TAPER FEM ST 13.5
00771301100 62885040 MOD ML TAPER FEM ST 11
65771301100 62939041 MOD ML TAPER FEM ST 11 HATCP
00771301000 62938997 MOD ML TAPER FEM ST 10
00771300500 63006851 MOD ML TAPER FEM ST 5
00771300900 62927082 MOD ML TAPER FEM ST 9.0
00771300500 63006852 MOD ML TAPER FEM ST 5
00771301100 62905574 MOD ML TAPER FEM ST 11
00771300600 63024189 MOD ML TAPER FEM ST 6
00771301100 62998426 MOD ML TAPER FEM ST 11
00771301100 63024240 MOD ML TAPER FEM ST 11
00771300900 63024220 MOD ML TAPER FEM ST 9.0
00771300700 63024204 MOD ML TAPER FEM ST 7.5
00771301000 63024229 MOD ML TAPER FEM ST 10
00771301000 63024230 MOD ML TAPER FEM ST 10
00771301100 63024239 MOD ML TAPER FEM ST 11
00771300700 63024205 MOD ML TAPER FEM ST 7.5
00771300700 63024206 MOD ML TAPER FEM ST 7.5
00771301100 63024241 MOD ML TAPER FEM ST 11
00771300900 63024219 MOD ML TAPER FEM ST 9.0
00771301200 63024262 MOD ML TAPER FEM ST 12.5
00771301100 63024238 MOD ML TAPER FEM ST 11
00771301300 63024245 MOD ML TAPER FEM ST 13.5
00771301100 63024237 MOD ML TAPER FEM ST 11
00771300700 63024201 MOD ML TAPER FEM ST 7.5
00771301000 63024228 MOD ML TAPER FEM ST 10
00771300900 63024218 MOD ML TAPER FEM ST 9.0
00771300600 63024187 MOD ML TAPER FEM ST 6
00771300900 63024217 MOD ML TAPER FEM ST 9.0
00771301200 63024263 MOD ML TAPER FEM ST 12.5
00771300900 63024221 MOD ML TAPER FEM ST 9.0
00771301200 63024261 MOD ML TAPER FEM ST 12.5
00771300700 63024203 MOD ML TAPER FEM ST 7.5
00771301200 62927123 MOD ML TAPER FEM ST 12.5
00771300900 62927083 MOD ML TAPER FEM ST 9.0
00771300900 63024216 MOD ML TAPER FEM ST 9.0
00771300600 63024188 MOD ML TAPER FEM ST 6
00771300700 63024202 MOD ML TAPER FEM ST 7.5
00771300600 63024184 MOD ML TAPER FEM ST 6
00771301100 63024234 MOD ML TAPER FEM ST 11
00771300900 63024210 MOD ML TAPER FEM ST 9.0
00771300700 63024195 MOD ML TAPER FEM ST 7.5
00771300700 63024196 MOD ML TAPER FEM ST 7.5
00784801400 62924878 KINECTIV MODULAR NECK X
00771300900 63024211 MOD ML TAPER FEM ST 9.0
00771301000 63024226 MOD ML TAPER FEM ST 10
00771300700 63024197 MOD ML TAPER FEM ST 7.5
00771300600 63024186 MOD ML TAPER FEM ST 6
00771300700 63024198 MOD ML TAPER FEM ST 7.5
00771300700 63024199 MOD ML TAPER FEM ST 7.5
00771301200 63024258 MOD ML TAPER FEM ST 12.5
00771300900 63024214 MOD ML TAPER FEM ST 9.0
00771301200 63024256 MOD ML TAPER FEM ST 12.5
00771301000 63024227 MOD ML TAPER FEM ST 10
00771300900 63024213 MOD ML TAPER FEM ST 9.0
00771301200 63024259 MOD ML TAPER FEM ST 12.5
00771301100 63024236 MOD ML TAPER FEM ST 11
00771300900 63024215 MOD ML TAPER FEM ST 9.0
00771301100 63024235 MOD ML TAPER FEM ST 11
00771301200 63024257 MOD ML TAPER FEM ST 12.5
00771300500 63024180 MOD ML TAPER FEM ST 5
00771300600 63024183 MOD ML TAPER FEM ST 6
00771301300 62939008 MOD ML TAPER FEM ST 13.5
00771300700 63024193 MOD ML TAPER FEM ST 7.5

 


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