Z-1822-2011

Ossur Total Knee, Model Number: 2100 The Total Knee 2100 is an external prosthetic knee joint. It is a...

Name: Z-1822-2011 Ossur Total Knee, Model Number: 2100 The Total Knee 2100 is an external prosthetic knee joint. It is a...
Creator: Ossur Engineering, Inc
Published: 2011-02-11
License: https://open.fda.gov/license/

Ossur Engineering, Inc / initiated 2011-02-11 / Terminated / root cause: manufacturing process

FDA source

Ossur Engineering, Inc began a recall of Ossur Total Knee, Model Number: 2100 The Total Knee 2100 is an external prosthetic knee joint. It is a polycentric knee designed for multi-speed ambulators... on 2011-02-11. The reason FDA records is "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 compromise knee function prematurely". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1822-2011
Status: Terminated
Initiated: 2011-02-11
Posted: 2011-03-25
Terminated: 2012-02-29
Recalling firm: Ossur Engineering, Inc
Product: Ossur Total Knee, Model Number: 2100 The Total Knee 2100 is an external prosthetic knee joint. It is a polycentric knee designed for multi-speed ambulators, higher impact levels and heavier loads.
Product code: ISY Joint, Knee, External Limb Component
Reason for recall: 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 compromise knee function prematurely.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Ossur initiated a Safety Notice (Voluntary Product Recall) letter on February 11, 2011, via US Postal Service Registered Mail. The recall letter informed the affected customers of the reason for the recall and the product affected. Ossur requested their distributor and providers take the following action: (1) Please identify the users of each of the Total Knee 2100 model devices listed above; (2) Also, please check your inventory and isolate any recalled devices you have on hand but have not fitted on users. Customers were also informed that a representative from Ossur customer service will be contacting them to coordinate replacement of the affected devices. The letters were followed by phone calls placed by a trained Ossur Customer Service Representative to each customer after US distributors provided Ossur with customer contact information. For questions regarding this recall call 517-629-8890.
Quantity in commerce: 142 units
Distribution: Worldwide Distribution - USA including CA, CO, FL, LA, MD, MI, MO, NJ, NY, OH, TN, VA,, and WA and the countries of Australia, Canada, Czech Republic, Germany, France, United Kingdom, Ireland, Italy, Japan, The Netherlands, Russian Federation, Sweden and Turkey.
Product codes and lots: Serial Numbers (new units):13241, 13243, 13245, 13246, 13247, 13248, 13251, 13252, 13253, 13254, 13255, 13256, 13259, 13260, 13261, 13262, 13263, 13264, 13265, 13266, 13267, 13268, 13269, 13270, 13271, 13272, 13282, 13284, 13285, 13286, 13287, 13289, 13290, 13293, 13296, 13297, 13298, 13300, 13301, 13302, 13304, 13306, 13307, 13308, 13309, 13310, 13311, 13312, 13313, 13314, 13315, 13317, 13318, 13319, 13320, 13321, 13322, 13323, 13324, 13325, 13326, 13327, 13329, 13330, 13331, 13332, 13333, 13334, 13335, 13336, 13337, 13338, 13339, 13340, 13341, 13342, 13344, 13345, 13346, 13347, 13348, 13349, 13350, 13351, 13352, 13353, 13354, 13358, 13360, 13363, 13364, 13365, 13368, 13369, 13370, 13371, 13372, 13373, 13374, 13375, 13376, 13377, 13378, 13379, 13380, 13381, 13384, 13385, 13386, 13387, 13393, 13394, 13395, 13397, 13399, 13400, 13401, 13407, 13409, 13410, 13411, 13412, 13413, 13414, 13415, 13416, 13417, 13418, 13420, 13431 Repairs units: 9611, 10325, 10616, 11615, 11747, 11795, 12091, 12092, 12097, 12098, 12101, 12104

Product code ISY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)