Class 2 Device Recall Stryker Strykeflow Electrocautery Probe

• Date Initiated by Firm: September 12, 2019
• Create Date: March 17, 2020
• Recall Status: Terminated on October 31, 2022
• Recall Number: Z-1509-2020
• Recall Event ID: 85100
• 510(K)Number: K934094
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926; ; This products was distributed with the following sheath/probe:; 0250070451-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Spatula-Tip,; 0250070452-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, J-TIP,; 0250070453-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, L-TIP,; 0250070455-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Needle Tip
• Code Information: Lot Numbers: 010818-02, 010818-05, 010818-06, 010818-07, 010818-08, 010818-09, 040816-01, 040816-02
• Recalling Firm/ Manufacturer: Stryker Corporation; 5900 Optical Ct; San Jose CA 95138-1400
• For Additional Information Contact: Brent Ladd; 408-754-2000
• Manufacturer Reason for Recall: Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This could lead to a compromised insulation, leading to unintentional flow of electricity to the patient. The sheath/probe is packaged separately.
• FDA Determined Cause: Other
• Action: On September 25, 2019 and November 26, 2019, the firm sent an "Urgent Medical Device Recall Notification" letter to all consignees via USPS mail. In addition, to informing consignees about the recall, they recall letter asked consignees to take the following actions: Actions to be taken by the Customer/User: 1. Inform individuals within your organization who need to be aware of this device removal. 2. Check all stock areas and/or operating room storage to determine if any devices with the affected Strykeprobe Sheath lot numbers from Attachment A are at your facility. - a. If you would like a list of all affected probe lot numbers, please email EndoRecall@Stryker.com 3. If affected product is found, segregate the product and call Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return and issuance of credit or replacement (upon availability). - a. Remove the affected sheath, quarantine, and discontinue use of the identified non-conforming recalled sheath(s). - b. When returning units, please enclose Business Reply Form on Attachment B. 4. If affected product is NOT found: - a. Please complete Business Reply Form on Attachment B and return to EndoRecall@Stryker.com 5. Please forward a copy of this letter to any other personnel within your facility you deem appropriate. 6. Please send any questions to EndoRecall@Stryker.com.
• Distribution: OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea
• 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 = GEI and Original Applicant = STRYKER CORP.