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Terminated

Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Code: HT025HI

FDA Recall Z-0135-2007 · Posted 2006-11-02

Recalling FirmDePuy Spine, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2006-10-10
Date Terminated2017-03-27
Product Quantity2272 units

Reason for Recall

Sterility of device is compromised due to loss of package integrity

Firm Action

DePuy Spine notified US consignees by letter via FedEX on 10/10/06 addressed to Materials Management. Outside the US noitifcation made to DePuy Spine and Distributors, recalls will be conducted by the foreign subsidiaries.

Root Cause

Other

Distribution Pattern

Nationwide and Australia, New Zealand, Germany, Canada, Czech Republic, Netherlands, Portugal, Sweden, UK, Japan, Indonesia, Italy, Belgium, Hong Kong, Poland, Spain, Switzerland, Taiwan, Turkey, Chile, Egypt, Guatemala, Hungary, Israel, Greece, Thailand, Mexico, Colombia, Venezuela, Slovenia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993099BREMER HALO SYSTEM TITANIUM SKULL PINDepuyacromed · 1999-12-15K915800BREMER HALO SYSTEM CERVICAL TRACTION SKULL PINBremer Medical, Inc. · 1992-03-16

Official Source

View FDA Recall →

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

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