Smart Correction External Fixation Struts: Collar Release Pin May Back Out
The collar release pin on affected Smart Correction Dual Joint Express Struts may back out, preventing proper length adjustment and potentially delaying surgical correction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with a mechanical malfunction (collar pin backing out) that affects device functionality. Although no hospitalizations or injuries have been reported, the device failure creates a risk of delayed surgical correction, fitting the rubric criterion for a risk-of-harm product with no reported injury.
Plain-English summary
Wishbone Medical, Inc. is recalling the Smart Correction Dual Joint Express Struts, an external skeleton fixation device used in orthopedic surgery. The recall affects 195 units distributed nationwide in South Carolina.
The company identified that the collar release pin may back out during use on affected units. This mechanical failure prevents users from adjusting the device length as intended, which may lead to delays in surgical correction.
Patients and healthcare providers are advised to contact Wishbone Medical, Inc. for additional information and to determine if their device is affected. Users should not use devices with damaged or loose collar release pins.
The recalled product
- Product
- 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
- Manufacturer
- Wishbone Medical, Inc.
- Affected units
- 195
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distribution
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