Zimmer ® M/L Taper with Kinectiv® Technology Recall

Saunders & Walker PA > Zimmer ® M/L Taper with Kinectiv® Technology Recall

ZIMMER – CLASS 1 RECALL

Zimmer ML Taper with Kinective(r) Technology RecallAlthough only on the market for less than one month, from March 31, 2015 through April 20, 2015, the FDA announced that a Class 1 Recall is in effect as of June 8, 2015, for Zimmer’s M/L Taper with Kinectiv® Technology. A Class 1 recall is the most urgent of recalls classified by the FDA.

The recalled product was listed on Zimmer’s website as having a unique ability to allow a surgeon to tailor the hip implant to fit the patient during arthroplasty, a surgical repair of a diseased joint.

CONTINUED PROBLEMS WITH MODULAR NECK SYSTEMS

The product was designed to “precisely match a wide range of male and female anatomies without compromise" through a broad spectrum of modular neck components. Their new “Kinectiv® technology allowed a surgeon the flexibility to adjust the length of the affected leg, relieve nerve impingement, allow a better range of motion, and to make sure the hip remained stable.

The Zimmer® M/L Taper with Kinectiv® Technology uses a modular neck system, a component that is inserted into the femoral stem at a fixed angle. Kinectiv® technology allowed a greater or lesser degree of angle. A taper is used to connect the two components.

The modular neck designs of other manufacturers have a troubled history as well. The Stryker Rejuvenate was a modular neck design that was recalled in 2012 and generated thousands of lawsuits that were settled for billions of dollars. The Wright Medical Profemur was a modular neck that had a high incidence of fracturing when they made the neck from titanium resulting in hundreds of lawsuits. While the modular neck design sounds like it might have some benefits I don’t think there is any solid medical literature of study that concludes that the modular neck design actually benefits patient outcomes.

REASON FOR ZIMMER RECALL

The recall announcement stated that Zimmer found a higher than expected amount of manufacturing residue on the products. The residue is not specifically named and the source is ambiguous. However, modular neck technology is well-known to have complications for corrosion where the metal neck snaps on to the femoral stem. Metal debris discharge into the bloodstream causing dangerously high levels of metal toxicity. This condition, known as metallosis, can cause inflammation, pain, swelling and tenderness, elevated temperatures, and at times, a gray discoloration can be seen around the implant area. Zimmer notified distributors, doctors and hospitals on May 18, 2015.

WHAT PATIENTS AFFECTED BY THE ZIMMER RECALL CAN DO

If you have one of these devices you should get legal advice immediately. If you would like to talk to one of our experienced staff, please call (800) 748-7115. You can also contact Joe Saunders via form by clicking here.

Products Being Recalled:

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

  • Free Case Evaluation

    • This field is for validation purposes and should be left unchanged.

  • Practice Areas