Recall Z-2468-2018
Fx Solutions · initiated June 4, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: UDI: 03701037300435 Lot Numbers: K238, K240, K689R, K1119, K1120, K1121, K1844, L1730, L1737, L1748, L1756, L1764, L1820, M1042 OUS only: K237, K239
Reason for recall
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
FDA-determined cause: Package design/selection
Action taken
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.
Details
- Recall number
- Z-2468-2018
- Initiated
- June 4, 2018
- Terminated
- April 5, 2019
- Product code
- HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- Quantity
- 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
- Recalling firm
- Fx Solutions, Viriat, Rhone-Alpe
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2469-2018 Class II | Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to…Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. | 06/04/2018Terminated |