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The year 2017 saw a substantial number of knee replacement recalls by the FDA, all of which were classified as Class 2 device recalls. The FDA defines a Class 2 recall as “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”. An FDA recall order forces the manufacturer in question to take action towards addressing a problem with a certain device in violation of FDA law.
In addition to FDA forced recalls, medical device manufacturers may issue voluntary recalls in which a potential problem might risk their reputation. The list of knee replacement recalls for 2017 below consists of only FDA recalls.
Zimmer Biomet, the leading competitor in the knee replacement market, maintains a broad product portfolio that has won considerable popularity among consumers. The company’s leading market share in the knee replacement device market was largely attributed to its Persona ® The Personalized Knee System, which received approval from the FDA in 2013, as well as to the Oxford Partial Knee System which celebrated its 40th anniversary in 2016 and is the most widely used partial knee replacement system in the world. Other significant Zimmer Biomet brands include the Vanguard® Knee System and NexGen® Complete Knee Solution. However, along with their wide range of devices, the company was also subject to the largest number of FDA recalls in 2017.
Most notably, on February 22nd, Zimmer Biomet was issued a total of 5 recall orders pertaining to their Oxford product line due to potential alumina inclusion in the finished product that could lead to cracking and separation. Products affected included the Oxford Partial Knee System Right and Left Medial Tibial Tray (of various sizes), Femoral Slap Hammer and Tibial Resector Body Tube & Guides, as well as the Oxford Unicompartmental Knee Phase 3 Tibial Impactor and various polyethylene implants: Sports Med, Repicci II Tibial Components.
Other knee replacement recalls by Zimmer Biomet in 2017 included:
|Date||January 6th, 2017|
|Reason for Recall||Mislabeling of right Oxford Fixed Lateral Bearings as left Bearing|
|Product(s) Affected||Oxford Fixed Lateral Bearing Size F Right|
|Date||January 28th, 2017|
|Reason for Recall||Drill bit larger than process specification|
|Product(s) Affected||Vanguard 360 Revision Knee System|
|Date||January 28th, 2017|
|Reason for Recall||Mislabeling of OSS Modular Proximal Tibia as AVL Modular Proximal Tibia which could lead to delay in surgery or revision|
|Product(s) Affected||Orthopedic Salvage System (OSS) 9cm|
|Date||February 16th, 2017|
|Reason for Recall||Potential alumina inclusion in finished product that could lead to cracking and separation|
|Product(s) Affected||Oxford Vanguard Total Knee, PUNCH THRU TRL PLATES, 63MM|
|Date||March 27th, 2017|
|Reason for Recall||Endotoxin level higher than process maximum limits|
|Product(s) Affected||Various polyethylene implants: Knees, Revision Tibial Tray Systems, Oxford Partial Knee, Orthopedic Salvage System, Vanguard Complete Knee System, Vanguard SSK Revision System, Biomet Patella, Maxim Complete Knee System, Biomet Series A Patella, Vanguard 360 Revision System, Vanguard Deep Dish Rotating Platform, Biomet CP Bearings|
|Date||April 25th, 2017|
|Reason for Recall||Pegs shear post-operatively|
|Product(s) Affected||Regenerex Patella: RGX 3 PEG SER A PATELLA (various sizes)|
|Date||November 8th, 2017|
|Reason for Recall||Custom implant for patient with nickel allergy contains nickel in CoCr Mo screw|
|Product(s) Affected||Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee|
Smith & Nephew
The last FDA ordered knee replacement recall in 2017 was issued to Smith & Nephew for a mix up of 5mm screws instead of 10mm screws for their LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE.
Smith & Nephew is another major competitor in the knee replacement market. The company’s sales in the market experienced massive growth in 2017, which was greatly attributed to their JOURNEY II Total Knee, as well as to the LEGION Revision Knee System and ANTHEM Total Knee System.
For Further Information
More on the orthopedic large joints replacement market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Orthopedic Large Joint Devices. This report covers the following market segments: hip implants, knee implants, and bone cement.
The iData series on the market for orthopedic large joint devices covers the U.S., India, Japan, China, and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about orthopedics large joint replacement market data or procedure data, register online or email us at [email protected] for an U.S. Market Report Suite for Orthopedic Large Joint Devices brochure and synopsis.