Recall Z-2469-2018

Fx Solutions · initiated June 4, 2018

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Fx 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 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: 03701037300510 Lot Numbers: J1123, K231, K232, K233, K234, K235, K1117, K1118, K1418, K1419, K1625, L1271, L1272, L1727, L1729, L1736, L1747, L1755, L1819, M1041 France only: K532R, L1763

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-2469-2018
Initiated
June 4, 2018
Terminated
April 5, 2019
Product code
HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Quantity
145 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

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2468-2018 Class IIFx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 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