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Terminated

M/DN Intramedullary Fixation Humeral Nail

FDA Recall Z-1004-04 · Posted 2004-07-20

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2004-03-16
Date Terminated2004-07-02
Product Quantity33 units

Reason for Recall

One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation.

Firm Action

Units were distributed to twelve (12) consignees in the US and seven (7) foreign consignees (China, Japan, Korea, El Salvador, Singapore, Taiwan and UK)

Root Cause

Other

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K965098INTRAMEDULLARY NAIL SYSTEMZimmer, Inc. · 1997-02-28

Official Source

View FDA Recall →

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

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