Orthopedic Growth Control Plating System Recalled for Incorrect Implant Material
Wishbone Medical recalls the WishFIX Growth Control Plating System because some units contain Stainless-Steel implants instead of the labeled Titanium implants. The recall affects 60 units distributed in Florida, New Jersey, and Connecticut.
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 an FDA Class II recall of an orthopedic implant device with a material substitution error. The source text does not report any illnesses, injuries, or hospitalizations. Per the severity rubric, a Class II recall without reported harm involving a risk-of-harm medical device receives a score of 3 (High).
Plain-English summary
Wishbone Medical, Inc. is recalling the WishFIX Growth Control Plating System, Model Number TEFCS28-080US, because certain units were incorrectly packed with Stainless-Steel implants instead of Titanium implants as indicated on the packaging and part number.
The recall affects 60 units distributed in the United States to Florida, New Jersey, and Connecticut. The affected lot number is 28042.
Material substitution in orthopedic implants may affect biocompatibility and mechanical performance, as stainless steel and titanium have different properties. Patients or healthcare providers who received products from this lot should verify the actual implant material before use and contact the manufacturer if they have received affected units.
If you have this product or placed it in inventory, contact Wishbone Medical, Inc. immediately for replacement or further instructions.
The recalled product
- Product
- WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
- Manufacturer
- Wishbone Medical, Inc.
- Affected units
- 60
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 (3)
- Model Number: TEFCS28-08-US
- UDI/DI: B562TEFCS2808US0
- Lot Number: 28042
Distribution
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