ClearanceBrief
Recall Z-0994-04 ยท LXH Orthopedic Manual Surgical Instrument

Howmedica Osteonics Corp.

T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035.

DateJul 20, 2004 (initiated Mar 31, 2004)
StatusTerminated
ReasonTargeting device may become distorted upon repeated autoclaving.
Root causeOther
ActionOn March 31, 2004 recall letters and product accountability forms were sent via FedEx.
Quantity32 devices
DistributionThere were 19 consignees which are Stryker sales representatives and subsidiaries nationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.