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TEHLIN
TEH LIN PROSTHETIC & ORTHOPAEDIC INC. · Model C-TK-4002 · UDI-DI 04719883460318
1
510(k) clearances
494
Adverse events (3 deaths)
17
Recalls
65
Facilities
Description
HY-STAN 4 BAR KNEE WITH 30° MANUAL LOCK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-10 | Ottobock Orthopedic Industrie | Some of the installed valve-inserts have a diameter smaller than the specification. |
| 2019-01-10 | Ottobock Orthopedic Industrie | Some of the installed valve-inserts have a diameter smaller than the specification. |
| 2019-01-10 | Ottobock Orthopedic Industrie | Some of the installed valve-inserts have a diameter smaller than the specification. |
| 2017-09-12 | Otto Bock Healthcare Product | 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 pyl |
| 2017-09-12 | Otto Bock Healthcare Product | 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 pyl |
| 2016-01-04 | Otto Bock Healthcare GmbH | Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error where the wrong Locti |
| 2015-07-16 | Otto Bock Healthcare GmbH | Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under cer |
| 2011-02-11 | Ossur Engineering, Inc | The recall was initiated based on a finding by Ossur that some units of the Total Knee 2100 produced from October 19th, 2010 until January 21st 2011, contained back links that may |
| 2009-08-10 | Ossur H / F | 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 fa |
| 2008-10-28 | Bock,Otto,Orthopedic Ind,Inc | Otto Bock Health Care LP has discovered that in some cases, the securing screws of the joint axes may not have been properly mounted. This can cause the axes to gradually move out |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.