WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-7
FDA device recall Z-1102-2023 · posted 2023-02-07 · Open, Classified
Recall details
- Recalling firm
- Wishbone Medical, Inc.
- Reason for recall
- Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.
- Action taken
- The firm visited the affected consignee on December 30, 2021, to discuss the product issue.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- KTT
- Quantity affected
- 195
- Distribution
- US Nationwide distribution in the state of South Carolina.
- Date initiated
- 2023-01-04
- Date posted
- 2023-02-07
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Smart Correction System (K193368) | Wishbone Medical, Inc. | 2020-09-18 |