Class 2 Device Recall Chesapeake Anterior Lumbar (AL) Removal Tool

• Date Initiated by Firm: September 08, 2021
• Create Date: October 13, 2021
• Recall Status: Terminated on May 17, 2024
• Recall Number: Z-0104-2022
• Recall Event ID: 88630
• 510(K)Number: K142487
• Product Classification: Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
• Product: Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
• Code Information: Lots CCUNA, HYMJ, KNCU
• FEI Number: 3008599177
• Recalling Firm/ Manufacturer: K2M, Inc; 600 Hope Pkwy SE; Leesburg VA 20175-4428
• For Additional Information Contact: Margarita Karan; 201-824-3302
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 Sales Representative will arrange for retrieval and removal of any instruments associated with this recall. 4. In the interim, until units can be removed from your facility by Stryker, there are no additional actions that users can and should take once the product has been segregated and removed from point of use. - If you desire additional training associated with these instructions, please contact our Regulatory Compliance team by calling 201.749.8090 or by email at Spine-RegulatoryActions@Stryker.com, or contact your local Sales representative. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. 6. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. 7. Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by using Stryker s online reporting site: https://www.stryker.com/productexperience. Additionally, adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program: https://www.accessdata.fda.gov/scripts/medwatch/index
• Quantity in Commerce: 23
• Distribution: Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OVE