Wishbone Medical, Inc. Recall 91526
Description: WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
Wishbone Medical, Inc. Recall 91526 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1102-2023 |
| Event ID | 91526 |
| Event Description | WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of South Carolina. |
| Quantity | 195 |
| Recall Reason | 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. |
| Device Classification | 20230215 |
| Device Code Info | XXS, Part No. 10-702-080095-0 UDI-DI B5621070208009500 Lot 1048176, 1048221 XS, Part No. 10-702-095115-0 UDI-DI B5621070209511500 Lot 1048177 Short, Part No. 10-702-115150-0 UDI-DI B5621070211515000 Lot 1048178, 1048222, 1048223 Medium, Part No. 10-702-140200 UDI-DI B562107021402000 Lot 1048179 Long, Part No. 10-702-190300-0 UDI-DI B5621070219030000 Lot 1048180 |
| Center Classification Date | 20230207 |
| Recall Initiation Date | 20230104 |
| Recalling Firm | Wishbone Medical, Inc. |
| Initial Notification | |
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