Z-1197-06

Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee

Name: Z-1197-06 Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee
Creator: Ossur North America Inc
Published: 2006-03-29
License: https://open.fda.gov/license/

Ossur Americas / initiated 2006-03-29 / Terminated

FDA source

Ossur North America Inc began a recall of Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee on 2006-03-29. The reason FDA records is "The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. Small cracks propagate through the pin cross section until the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1197-06
Status: Terminated
Initiated: 2006-03-29
Posted: 2006-07-04
Terminated: 2008-08-08
Recalling firm: Ossur Americas
Product: Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee.
Product code: ISY Joint, Knee, External Limb Component
Reason for recall: The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. Small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
FDA root cause: Other
Action: On 3/29/06 a press release was posted on OandP.com, an industry specific web site. An announcement listing involved serial numbers and contact phone numbers was also posted on the company''s web site, ossur.com. A two stage mailing has been constructed. The first letter sent to all customers March 30, 2006, describes the problem and models affected. The second letter, March 31, 2006, is customer specific and lists all of the involved serial numbers by model which were purchased by that customer. Telephone calls will be placed to customers who do not respond to the mailings.
Quantity in commerce: 285
Distribution: Distribution worldwide in Austria, Canada, Columbia, Hong Kong, Japan, Korea, Kuwait, Malaysia, Mexico, Taiwan, & New Zealand. Involved states are: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, AND WY.
Product codes and lots: Serial numbers: 5787 ¿ 6207 including the following repaired units outside the stated range. 5339, 5471, 5478, 5670.

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)