Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of the BUDDE Halo Neurosurgical Retr
FDA device recall Z-0781-03 · posted 2003-04-25 · Terminated
Recall details
- Recalling firm
- Ohio Medical Instrument Co Inc
- Reason for recall
- The component was manufactured with an insufficient weld that could break during use.
- Action taken
- The firm contacted their accounts by email and telephone on 2/26/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- GZT
- Quantity affected
- 43 components
- Distribution
- The units were shipped to domestic consignees in NY, NJ, IL, and FL; and to foreign customers located in Japan, Hong Kong, Korea, Great Britian, and Germany.
- Date initiated
- 2003-02-26
- Date posted
- 2003-04-25
- Date terminated
- 2003-12-01
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BUDDE-HALO RETRACTOR (K830332) | Ohio Medical Instrument Co., Inc. | 1983-03-02 |