Food, drugs, devices › Wishbone Medical, Inc.
Device recall: WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
FDA enforcement event 94405 is a device recall by Wishbone Medical, Inc. of Warsaw, IN, initiated 5 Apr 2024 and classified Class II, with 1 product record.
FDA defines Class II as 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. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Wishbone Medical, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Wishbone Medical, Inc., Warsaw, IN.
Reason for recall
"The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated."
Distribution
"US distribution to Florida, New Jersey and Connecticut."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1808-2024 | WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device. | 60 units | Class II | Ongoing | 22 May 2024 |
Context
Other enforcement events for Wishbone Medical, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Jan 2023 | WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-7 | Device | Class II | 1 |
| 30 Apr 2021 | WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-S | Device | Class II | 1 |
All 3 events for Wishbone Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution to Florida, New Jersey and Connecticut."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.