WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Numb
Summary
The FDA issued a Class II for WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton f by Wishbone Medical, Inc.. 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 o.
Details
Source
Device Recall
External ID
Z-1102-2023
Action Date
2023-02-15
Status
Ongoing
Category
device
Product 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
Lot/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
Quantity Affected: 195
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.
Distribution
US Nationwide distribution in the state of South Carolina.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-04
Company
Warsaw, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Wishbone Medical, Inc. has 5 FDA actions in our database, including 2 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Wishbone Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wishbone Medical, Inc. have FDA actions?
Wishbone Medical, Inc. has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1102-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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