Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.

The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.

Zimmer Biomet sent an Urgent Medical Device Recall letter dated April 5, 2018, to Distributors, Sales Representatives, and Distribution Managers. A separate recall letter was sent to Risk Managers on the same date. (Updated 3/20/19) On February 12, 2019, the firm issued notification of recall expansion. Further affected lots had been identified as part of the recall, and affected customers were notified. (/Update) Consignees were informed of the product issue and risk of non-functioning device and delays in surgery. All parties were instructed to review the notice, locate and quarantine affected product in inventory, return all affected product with a completed return form and mark "RECALL" on the outside of returned cartons, and return the completed customer response form. If you have further questions or concerns regarding this recall, please call (904)741-4400 extension 9133 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of operating hours will receive a voicemail prompt. For further questions, please call (574) 371-3071. (Updated 3/20/19) Alternatively, your questions may be emailed to [email protected]. (/Update)