Stryker Howmedica Osteonics Corp. Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE Intended Use: - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis - Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis - As an alternative to tibial osteotomy in patients with unicompart Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE Intended Use: - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis - Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis - As an alternative to tibial osteotomy in patients with unicompart
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
8 mm - LM/RL Catalog number 5630-G-108, Lot code NXDMEE, 12 mm -RM/LL Catalog number 5630-G-122 Lot code M8JMEE.
Products Sold
8 mm - LM/RL Catalog number 5630-G-108, Lot code NXDMEE; 12 mm -RM/LL Catalog number 5630-G-122 Lot code M8JMEE.
Stryker Howmedica Osteonics Corp. is recalling Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/L due to Label mix-up: Stryker Orthopaedics became aware of a lot for lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and T. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Label mix-up: Stryker Orthopaedics became aware of a lot for lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE.
Recommended Action
Per FDA guidance
Recall notifications entitled "URGENT PRODUCT RECALL" were sent via Federal Express on 11/25/2008 to Stryker branches, hospital risk management, Hospital Chief of Orthopaedics. For further information, please contact Stryker Howmedica Osteonics Corporation by telephone at 201-831-5718.
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