Recall Z-0104-2022 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
K2M, Inc
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
| Date | Sep 8, 2021 |
| Status | Terminated |
| Reason | Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery. |
| Root cause | Process control |
| Action | On September 8, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Actions Needed: 1. Immediately check your internal inventory to locate the product listed in the letter and remove them from their point of use. 2. Use the included Business Reply Form to reconcile any affected product. Complete the Business Reply Form even if there is no affected product identified. 3. Return the enclosed Business Reply Form by email to Spine-RegulatoryActions@Stryker.com to confirm receipt of this notification/document product segregation. Your account s Stryker Spine Sa |
| Quantity | 23 |
| Distribution | Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142487 | Chesapeake Stabilization System K2m, Inc., May 7, 2015 |