FDA Medical Device Recalls (openFDA)
Ossur: Ossur Total Knee Model Number 2100, external knee prosthesis.
- Recall number
- Z-1076-2007
- Recalling firm
- Ossur
- Product
- Ossur Total Knee Model Number 2100, external knee prosthesis.
- Status
- Terminated
- Initiated
- 2007-04-02
- Posted
- 2007-07-12
- Terminated
- 2008-05-28
- Reason
- Some units of the Total Knee Model 2100 produced from August 1, 2006 through October 4, 2006 may contain a faulty linkage component.
- 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
- 44
- Distribution
- Nationwide.
- Lot, serial or model codes
- 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.
- 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
- Ireland
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