| Class 2 Device Recall OTTO BOCK Kenevo knee joints | |
Date Initiated by Firm | September 12, 2017 |
Create Date | March 01, 2018 |
Recall Status1 |
Terminated 3 on January 19, 2021 |
Recall Number | Z-0814-2018 |
Recall Event ID |
79019 |
Product Classification |
Joint, knee, external limb component - Product Code ISY
|
Product | OTTO BOCK Kenevo knee joints Model 3C60 |
Code Information |
Serial Numbers: 201520007, 201520010, 201520012, 201520008, 201520009, 201522040, 201520002, 201520011, 201520006, 201522046, 201522043, 201520028, 201528134, 201528139, 201520013, 201522045, 201525069, 201525109, 201524051, 201524050, 201549087, 201550012, 201550020, 201550022, 201550017, 201550028, 201550027, 201550016, 201550036, 201550014, 201551005, 201550025, 201551028, 201551030, 201550040, 201551032, 201602031, 201602030, 201603014, 201603016, 201603023, 201602034, 201602036, 201602032, 201551034, 201603029, 201603027, 201603028, 201610008, 201601018, 201610010, 201610015, 201610019, 201610022, 201610020, 201611001, 201611010, 201520027, 201610030, 201610035, 201611012, 201603025, 201611002, 201611018, 201612018, 201612020, 201613021, 201613019, 201615008, 201618017, 201616010, 201613008, 201616004, 201616005, 201616012, 201618023, 201618021, 201618018, 201618019, 201618024, 201617031, and 201618025. |
Recalling Firm/ Manufacturer |
Otto Bock Healthcare Product Brehmstrase 16 Vienna Austria
|
For Additional Information Contact | Customer Service 800-328-3458 |
Manufacturer Reason for Recall | Otto Bock Healthcare Products GmbH has identified a design issue through extended durability
testing where the pylon clamping mechanism has the potential to cause damage to the
pylon. When used longer than 1.45 million cycles (which represents approximately 2.3
years of use of the knee joint under heavy usage conditions), AND the pylon clamp is overtightened
according to the labeled torque specification, AND the patient weighs at most
125kg it may be remote that the pylon breaks, and causing the patient to fall.
There have been no failures or complaints reported directly attributed to the failure mode
collapsed pylon.
In the US Market and in Canada, labeling requires a condition based service at three years.
In the rest of the world, a mandatory two year service interval is specified. Only the devices
in distribution in the United States and Canada are affected by this action.
|
FDA Determined Cause 2 | Device Design |
Action | On September 14, 2017 a letter was sent to all their consignees via 2nd day signature receipt required to customers instructing them to contact their patients and send in their devices for service within the first 2.3 years of use. The pylon clamp will be replaced at no charge. The pylon will also be inspected and replaced if necessary. The customer will be requested to complete a reply form indicating they have received the notice and intend to contact their patients to arrange for the requested service.
Customer Service: (800) 328-3458 Option 1
Loaner Service: (800) 328-3458 Option 3, then Option 1 |
Quantity in Commerce | 75 units |
Distribution | AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA
AU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU |
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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