T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035.
FDA device recall Z-0994-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Howmedica Osteonics Corp.
- Reason for recall
- Targeting device may become distorted upon repeated autoclaving.
- Action taken
- On March 31, 2004 recall letters and product accountability forms were sent via FedEx.
- Root cause
- Other
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 32 devices
- Distribution
- There were 19 consignees which are Stryker sales representatives and subsidiaries nationwide.
- Date initiated
- 2004-03-31
- Date posted
- 2004-07-20
- Date terminated
- 2004-06-03
- Location
- Mahwah, NJ
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