—#160377

Product

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K100238
Affected lot / code info: Item No. 814309460; Lot No. (Exp. Date) UDI: 737630 (06/14/2027) UDI (01)00887868038075 (17)270614 (10)737630

Why it was recalled

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Root cause (FDA determination)

Process change control

Action the firm took

Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: US nationwide distribution. Also Portugal and the Netherlands.

Timeline

Recall initiated: 2017-08-07
Terminated: 2019-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160377. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.