Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01. (Note: This product is not distributed in the United States).
FDA Recall Z-1702-2009 · Posted 2009-08-04
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2009-06-05
Date Terminated2009-12-22
Product Quantity120 of both products
Reason for Recall
Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.
Firm Action
Zimmer sent an Urgent Device Recall letter dated 6/5/09 to all consignees and instructed to locate and return the products.
Root Cause
Process control
Distribution Pattern
Worldwide distribution: USA, China, Germany, Japan, Korea and Thailand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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