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 disor
Check against the official notice below — it lists the full affected range.
Zimmer, Inc. is voluntarily recalling 752 M/L Taper with Kinectiv femoral stems and modular necks across 64 lots due to higher than allowed cytotoxicity levels. The recalled implants were distributed worldwide, including across numerous U.S. states and countries including Canada, Australia, Japan, Taiwan, France, Germany, Spain, and Italy. The company identified a reasonable probability that the cytotoxicity levels could cause an adverse biological response and require revision surgery.
The recall affects specific product codes and lot numbers listed in the recall record. According to the record provided, no remedy information is specified.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: Worldwide Distribution - US Nationwide in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OK, PA, TX, UT, VA, WA, WI and countries of Canada, Australia, Japan, Taiwan, France, Germany, Spain, and Italy. Quantity: 752 Lot/code info: 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 record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.