Stryker Howmedica Osteonics Corp. Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica Osteonics Corp. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica Osteonics Corp.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Ref. No. 5530-G-211 Lot code G9XF6 LAF974
Products Sold
Ref. No. 5530-G-211 Lot code G9XF6 LAF974
Stryker Howmedica Osteonics Corp. is recalling Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 H due to A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is act. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.
Recommended Action
Per FDA guidance
Notification letters and Product Accountability forms were sent on 12/8/2006 by Federal Express with return receipt.
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