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VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "...

FDA Device Recall #Z-0848-2016 — Class II — January 11, 2016

Recall Summary

Recall Number Z-0848-2016
Classification Class II — Moderate risk
Date Initiated January 11, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer Biomet, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 1305

Product Description

VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" 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. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected."

Reason for Recall

LDPE bag containing the implant adheres to the highly polished implant surface.

Distribution Pattern

Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada

Lot / Code Information

Item numbers: 00-7843-011-26 00-7843-011-56 00-7843-012-26 00-7843-012-56 00-7843-013-26 00-7843-013-56 00-7843-014-26 00-7843-014-56 00-7843-015-26 00-7843-015-46 00-7843-015-56 00-7843-016-26 00-7843-016-46 00-7843-016-56 00-7843-017-26 00-7843-017-46 00-7843-017-56 00-7843-018-26 00-7843-018-46 00-7843-018-56 00-7843-019-26 00-7843-019-46 00-7843-019-56 00-7843-020-26 00-7843-020-46 00-7843-020-56 00-7843-021-26 00-7843-021-46 00-7843-021-56 00-7843-022-26 00-7843-022-46 00-7843-022-56 lot numbers: 11003828 11004140 11004141 11004945 11005429 11005666 61633498 61699577 61704382 61710259 61710265 61721708 61735803 61735804 61735807 61735808 61735811 61741803 61741804 61741807 61746866 61752732 61757179 61757188 61759235 61759263 61759264 61759265 61760620 61768678 61768681 61769239 61775245 61775247 61781979 61781993 61781994 61786857 61786859 61786862 61807096 61815089 61829365 61829366 61834825 61840229 61840235 61840236 61840240 61840243 61844742 61844743 61848234 61848238 61848248 61852817 61852823 61876837 61879443 61879446 61879450 61884825 61884826 61884830 61902329 61902374 61902382 61910047 61910048 61910049 61910050 61910051 61910057 61910058 61915343 61915348 61920858 61920859 61920860 61932609 61932610 61932611 61937670 61937671 61937679 61937680 61946016 61946017 61946018 61946026 61956713 61956714 61956724 61963719 61963728 61974966 61993630 62003641 62003642 62003643 62003719 62006778 62011971 62025498 62025499 62025503 62025504 62025509 62029069 62034134 62043097 62043107 62045160 62053687 62053689 62053692 62054926 62054928 62067444 62067446 62071763 62071764 62077676 62077680 62077681 62085290 62085291 62085293 62085296 62089502 62089504 62089509 62097215 62097232 62097258 62097289 62097296 62102129 62107875 62107877 62107878 62116476 62116532 62132186 62132187 62133140 62135309 62135311 62135317 62135322 62143764 62143773 62147263 62147267 62153941 62153947 62158853 77000593 77000594 77000595 77000596 77000597 77000598 77000990 77001428 77001429 77001431 77001433 77001543 77001550

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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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