Recall Z-1705-2018 ยท JEY Plate, Bone
Zimmer Biomet, Inc.
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
| Date | May 7, 2018 (initiated Apr 5, 2018) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 aff |
| Quantity | 13175 |
| Distribution | worldwide Distribution - US Distribution to the states of : CA, FL, MO, NC, SC, TX, and WI., and to the countries of : Argentina, China, Colombia, Germany, Japan, Netherlands, South Africa, Thailand, and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003281 | LACTOSORB RAPIDFLAP Biomet, Inc., Aug 7, 2001 |