FDA Medical Device Recalls (openFDA)
Ossur H / F: Total Knee Junior Model Number 1100 Product Usage: The Total Knee Junior is an external polycentric prosthetic knee with a geometric locking system.
- Recall number
- Z-0965-2012
- Recalling firm
- Ossur H / F
- Product
- Total Knee Junior Model Number 1100 Product Usage: The Total Knee Junior is an external polycentric prosthetic knee with a geometric locking system.
- Status
- Terminated
- Initiated
- 2009-08-10
- Posted
- 2012-02-06
- Terminated
- 2012-02-06
- Reason
- Some units of the Total Knee Junior produced between November 25th, 2008 and through April, 2009 contain balancing units that may fail under extreme use over a long period. The fault is noncritical and no incidents or injuries resulting from this situation have been reported to Ossur at this stage. Over long term use (estimated to be in the four to six year range) the prosthetic device may fail a
- Root cause
- Nonconforming Material/Component
- Action
- Ossur sent a Safety Notice dated August 10, 2009 by mailed to all affected consignees. Ossur informed consignees of the above mentioned public reason for recall and asked consignees to take the following action: Identify the users of each of the Total Knee Junior model devices listed above and check inventory and isolate any recalled devices on hand but have not fitted on users. The letter states that Sue Fitzgerald from customer service will be contacting consignees in the next few days to coordinate replacement of the affected devices. For question call 1-(800) 219-2150, Ext: 4109. In addition, Ossur website: www.ossur.com we will be posting updates as appropriate.
- Quantity
- 141 units
- Distribution
- Worldwide Distribution - USA (nationwide) in the state of: AL, AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, and WV and the countries of: Australia, Canada, China, France, Germany, Hong Kong, Israel, Japan, Malaysia, Netherlands, New Zealand, Portugal, Puerto Rico, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, United Kingdom and United States.
- Lot, serial or model codes
- Serial Numbers: 8573, 8574, 8575, 8577, 8578, 8580, 8581, 8582, 8583, 8584, 8585, 8586, 8587, 8588, 8589, 8599, 8600, 8602, 8603, 8604, 8605, 8606, 8609, 8610, 8611, 8613, 8616, 8620, 8621, 8622, 8624, 8628, 8629, 8630, 8631, 8632, 8633, 8634, 8635, 8636, 8638, 8639, 8640, 8642, 8643, 8644, 8645, 8646, 8666, 8670, 8671, 8672, 8673, 8674, 8675, 8678, 8679, 8680, 8682, 8684, 8685, 8687, 8688, 8691, 8692, 8693, 8694, 8695, 8696, 8697, 8698, 8699, 8701, 8715, 8716, 8717, 8719, 8720, 8722, 8723, 8725, 8739, 8755, 8756, 8757, 8758, 8759, 8760, 8761, 8784, 8787.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ISY
- Firm FEI
- 3003764610
- Firm city
- Reykjavik
- Firm state
- not on file
- Firm country
- Iceland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28