Humelock Cemented Shoulder Prosthesis recallZ-2468-2018 · Fx Solutions · initiated Jun 4, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fx Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
FDA root cause category: Package design/selection
What the company is doing
The firm initiated the recall by email on 06/04/2018 in France, on 06/05/2018, to distributors in the US and elsewhere. The distributor (US Agent) sent the notice on to the division agents who store the product. The firm requested return of the units.
Recall details
- Recall number
- Z-2468-2018
- Status
- Terminated
- Initiated by the company
- Jun 4, 2018
- Recalling firm
- Fx Solutions
- Quantity
- 131 units
- Product code
- HSD
- FDA submissions
- K111097
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: France, Argentina, South Africa, Spain, Israel, Germany, Lebanon, Italy, Chile, Belgium, Greece, Mexico, Poland, Hong Kong, Switzerland
Product description
Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Code information (models, lots, serial numbers)
UDI: 03701037300435 Lot Numbers: K238, K240, K689R, K1119, K1120, K1121, K1844, L1730, L1737, L1748, L1756, L1764, L1820, M1042 OUS only: K237, K239
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Humelock Cemented Shoulder Prosthesis 106-5019Fx Solutions · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall1 report
Product lines
Other devices under the same FDA submission
7 devices cleared under K111097 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Humelock Cemented Shoulder System 106-5000Fx Solutions · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall1 report
- Humelock Cemented Shoulder Prosthesis 106-4316Fx Solutions · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented6 reports
- Humelock Cemented Shoulder Prosthesis 106-4300Fx Solutions · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented5 reports
- Humelock Cemented Shoulder Prosthesis 106-3914Fx Solutions · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented3 reports
- Humelock Cemented Shoulder Prosthesis 106-4600Fx Solutions · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented3 reports
- Humelock Cemented Shoulder Prosthesis 106-4617Fx Solutions · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2 reports
- Humelock Cemented Shoulder Prosthesis 106-3900Fx Solutions · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 80302).
- Z-2469-2018 · TerminatedFx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and othe…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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