Fix pins associated with Stealth Station Treatment Guidance Platform
This recall has been terminated (originally issued December 17, 2003).
- Recall Initiated
- October 31, 2003
- Posted
- December 17, 2003
- Terminated
- December 19, 2003
- Recall Number
- Z-0231-04
- Quantity
- 127 devices
- Firm Location
- Louisville, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Surgical devices intended for single use were not labeled for single use.
Distribution
Domestic distribution to CA,FL,GA,KS,TX. Foreign distribution to Belgium, France, Germany, Hong Kong, Japan. No military or government consignees.
Lot / Code Info
3'' fix pin - 9730476, Lot numbers 200302130552, 200302140566 and 200302260619. 5'' fix pin - 9730477, Lot numbers200302140564, and 200303030641.
Root Cause
Other
Action Taken
Consignees were notified by letter on 11/01/2003.