Z-1076-2007

Ossur Total Knee Model Number 2100, external knee prosthesis

Name: Z-1076-2007 Ossur Total Knee Model Number 2100, external knee prosthesis
Creator: Ossur
Published: 2007-04-02
License: https://open.fda.gov/license/

Ossur Iceland ehf. / initiated 2007-04-02 / Terminated

FDA source

Ossur began a recall of Ossur Total Knee Model Number 2100, external knee prosthesis on 2007-04-02. The reason FDA records is "Some units of the Total Knee Model 2100 produced from August 1, 2006 through October 4, 2006 may contain a faulty linkage component". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1076-2007
Status: Terminated
Initiated: 2007-04-02
Posted: 2007-07-12
Terminated: 2008-05-28
Recalling firm: Ossur Iceland ehf.
Product: Ossur Total Knee Model Number 2100, external knee prosthesis.
Product code: ISY Joint, Knee, External Limb Component
Reason for recall: Some units of the Total Knee Model 2100 produced from August 1, 2006 through October 4, 2006 may contain a faulty linkage component.
FDA root cause: Other
Action: On 4/2/07 a letter was mailed to all affected customers via certified mail, return receipt requested. All mailing will be followed by telephone calls from an Ossur Customer Service Representative. Customers were notified that Ossur will replace the affected knees with units carrying a two-year warranty from the date of replacement. Ossur will undertake a sub-recall by notifying the one affected distributor by letter on 4/2/07. Ossur will follow up with this distributor by telephone and request a list of consignees that the distributor sold the product to so that Ossur can directly contact each of those consignees. Upon receipt of this list, Ossur will then communicate the recall information directly to these consignees.
Quantity in commerce: 44
Distribution: Nationwide.
Product codes and lots: US affected Serial Numbers (1) New units: 9056, 9062, 9063, 9088, 9089, 9090, 9092, 9094, 9095, 9096, 9097, 9099, 9100, 9101, 9102, 9103, 9104, 9105, 9106, 9107, 9108, 9109, 9110, 9111, 9112, 9113, 9114, 9115, 9116, 9117, 9118, 9127, 9129, 9130, 9159, 9160, 9162, 9163, 9166 and 9169. (2) Repaired units: 5138, 5141, 6624 and 9098.

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)