The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the implantation of St
FDA device recall Z-1554-05 · posted 2005-09-21 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The threaded part of the instrument may break when connected to the screw and potentially result in an adverse health consequence.
- Action taken
- The notification letters and product accountability forms were sent to their branches/agencies and the one hospital via Fedex on 5/16/2005 with return receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- MNH
- Quantity affected
- 107
- Distribution
- Stryker distributes their product though branches/agencies and occassionally directly to hospitals. These branches/agencies are located nationwide and will deliver the device to the medical facility.
- Date initiated
- 2005-05-16
- Date posted
- 2005-09-21
- Date terminated
- 2005-12-02
- Location
- Mahwah, NJ
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