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M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabu...

FDA Device Recall #Z-1699-2015 — Class I — May 18, 2015

Recall Summary

Recall Number Z-1699-2015
Classification Class I — Serious risk
Date Initiated May 18, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 752

Product 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.

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 Pattern

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.

Lot / Code Information

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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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