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Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot… recallZ-0869-2009 · Stryker Howmedica Osteonics Corp. · initiated Nov 25, 2008

Terminated All recalls posted in January 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-0869-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 25, 2008
Posted by the FDA
Jan 12, 2009
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
8 mm - 1 unit; 12 mm - 8 units.
Product code
HRY
FDA submissions
K071881
Distribution
Nationwide distribution: Product was distributed to 7 Stryker branches and one hospital.

Product description

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 unicompartmental osteoarthritis, where bone stock is of poor quality or inadequate for other reconstructive techniques as indicted by deficiencies of the femoral condyle/tibia plateau. These components are intended for implantation with bone cement. Stryker Orthopaedics; Howmedica Osteonics Copr. 325 Corporate Drive Mahwah, NJ 07430

Code information (models, lots, serial 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.

Other devices under the same FDA submission

25 devices cleared under K071881 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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