| Class 2 Device Recall NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CONIDIUM SURFACE HARDENING PROCESS | |
Date Initiated by Firm | January 11, 2016 |
Date Posted | February 22, 2016 |
Recall Status1 |
Terminated 3 on May 23, 2017 |
Recall Number | Z-0833-2016 |
Recall Event ID |
73142 |
510(K)Number | K962196 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | NexGen Knee CR Porous FEM
NexGen Knee CR Precoat FEM
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
various sizes
"" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only." |
Code Information |
Item numbers: 00-5970-011-31 00-5970-011-32 00-5970-012-31 00-5970-012-32 00-5970-013-31 00-5970-013-32 00-5970-013-33 00-5970-013-34 00-5970-014-31 00-5970-014-32 00-5970-014-33 00-5970-014-34 00-5970-015-31 00-5970-015-32 00-5970-015-33 00-5970-015-34 00-5970-016-31 00-5970-016-32 00-5970-017-31 00-5970-017-32 00-5970-018-31 00-5970-018-32 00-5972-011-31 00-5972-011-32 00-5972-012-31 00-5972-012-32 00-5972-013-33 00-5972-013-34 00-5972-014-33 00-5972-014-34 00-5972-015-33 00-5972-015-34 00-5972-016-31 00-5972-016-32 00-5972-017-31 00-5972-017-32 00-5972-018-31 00-5972-018-32 Lot numbers: 11003380 11003415 11003477 11003574 11003583 11003586 11003597 11003601 11003602 11003612 11003613 11003626 11003644 11003666 11003673 11003832 11003870 11003871 11003889 11003890 11003893 11003941 11003942 11003954 11004035 11004058 11004080 11004189 11004302 11004500 11004566 11004597 11004683 11004766 11004817 11004868 11004869 11004870 11004946 11004950 11004952 11004954 11004957 11004958 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Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 1800 W Center St Warsaw IN 46580-2304
|
For Additional Information Contact | Consumer Relations Call Center 800-447-5633 |
Manufacturer Reason for Recall | LDPE bag containing the implant adheres to the highly polished implant surface. |
FDA Determined Cause 2 | Process control |
Action | Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.
For questions regarding this recall call 800-447-5633. |
Quantity in Commerce | 18093 |
Distribution | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JWH
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