—#93405

Product

TRABECULAR METAL FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31. The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary defects in the distal femur and to provide for a stable platform for an LCCK or Rotating Hinge Knee femoral component.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K040630
Affected lot / code info: Lot: 60683028, Manufactured: 6/05/2007

Why it was recalled

Zimmer, Inc. has determined that there is a potential for the packages to be mislabeled. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Zimmer, Inc. sent Urgent: Device Removal letters, dated July 9, 2010, identifying the affected product and stating the issue. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left. The letter also discussed the clinical implications along with required actions. Customers are to perform a physical count of all affected product and record the data on the Inventory Return Certification Form included with the letter. In addition, customers should complete and return the Inventory Certification and User Facility/HCP Documentation Forms. Affected product along with the Inventory Return Certification Form should be returned. Zimmer, Inc. should be contacted at 1-800-613-6131 if there are any questions or need for additional information.

Recalling firm

Firm: Zimmer Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide Distribution -- USA, Canada, Singapore, Australia, and Switzerland, Spain, UK, Sweden, and Israel.

Timeline

Recall initiated: 2010-07-05
Posted by FDA: 2010-09-20
Terminated: 2010-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93405. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.