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

NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.

FDA Recall Z-1376-2013 · Posted 2013-05-24

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeHTW
Date Initiated2013-03-27
Date Terminated2017-01-26
Product Quantity69 units

Reason for Recall

Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide.

Firm Action

Zimmer sent an "URGENT MEDICAL DEVICE RECALL LETTER" dated April 19, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020295NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0Implex Corp. · 2002-02-12K012866THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0Implex Corp. · 2001-09-26

Official Source

View FDA Recall →

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

↑