Ossur Grjothals 5 Reykjavik Ireland Ossur Total Knee Model Number 2100, external knee prosthesis. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ossur Total Knee Model Number 2100, external knee prosthesis.
Brand
Ossur Grjothals 5 Reykjavik Ireland
Lot Codes / Batch Numbers
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.
Products Sold
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.
Ossur Grjothals 5 Reykjavik Ireland is recalling Ossur Total Knee Model Number 2100, external knee prosthesis. due to Some units of the Total Knee Model 2100 produced from August 1, 2006 through October 4, 2006 may contain a faulty linkage component.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some units of the Total Knee Model 2100 produced from August 1, 2006 through October 4, 2006 may contain a faulty linkage component.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026