Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial Baseplate stem. P/N 801-01-013

FDA Recall Z-0349-2012 · Posted 2011-12-02

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2011-10-26
Date Terminated2012-09-05
Product Quantity30 units

Reason for Recall

The strike plate may dislodge from the broach stem handle during impaction of the device.

Firm Action

DJO Global sent an URGENT FIELD SAFETY NOTICE letter dated October 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the information to all those who need to be aware within their organization or to any organization where the affected devices have been transferred. Customers should contact Customer Service to place a replacement order and receive an RMA number and return all affected devices using the RMA number. For any questions call (512) 834-6255.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - USA including AR, AZ, CA, LA, MD, NY, TX, UT and Puerto Rico and the countries of United Kingdom and Italy

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970031FOUNDATION KNEE SYSTEM TIBIAL COMPONENTEncore Orthopedics, Inc. · 1997-04-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑