Z-2468-2018Class II

Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019

Name: Z-2468-2018 Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019
Creator: Fx Solutions
Published: 2018-06-04
License: https://open.fda.gov/license/

Fx Shoulder Solutions SAS / initiated 2018-06-04 / Terminated / root cause: packaging

FDA source

Fx Solutions began a recall of 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... on 2018-06-04. FDA classified it as Class II and gives the reason as "Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2468-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-04
Posted: 2018-07-17
Terminated: 2019-04-05
Recalling firm: Fx Shoulder Solutions SAS
Product: 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.
Product code: HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Reason for recall: Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: 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.
Quantity in commerce: 131 units
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 codes and lots: UDI: 03701037300435 Lot Numbers: K238, K240, K689R, K1119, K1120, K1121, K1844, L1730, L1737, L1748, L1756, L1764, L1820, M1042 OUS only: K237, K239

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2468-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2468-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17
Z-2469-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-17

Product code HSD

K111097Class IIHumelock Cemented Shoulder ProsthesisFx Solutions / cleared 2011-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)