Recall Z-1735-2019 ยท KWP Appliance, Fixation, Spinal Interlaminal
Zimmer Biomet, Inc.
Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced st
| Date | Nov 14, 2018 |
| Status | Terminated |
| Reason | Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking. |
| Root cause | Process control |
| Action | On November 14, 2018, the firm sent an "Urgent Medical Device Recall" letters dated November 14, 2018, to its affected customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete the included Certificat |
| Quantity | 64 |
| Distribution | US Distribution to CA, NC, and NY; and International to Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151224 | Lineum OCT Spine System Biomet Spine, Jun 30, 2015 |