T2 Recon Nail System.
FDA Recall Z-0060-06 · Posted 2005-10-15
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHSB
Date Initiated2005-08-12
Date Terminated2006-07-20
Product Quantity4698 PIECES
Reason for Recall
The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility.
Firm Action
The notification letters and product accountability forms were sent via FedEx on 8/12/2005 with return receipt.
Root Cause
Other
Distribution Pattern
The devices have been distributed to Stryker Branches/Agencies, Hospitals nationwide, and Government hospitals. There are no international customers.
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.