Recall Z-1620-2025 ยท LXH Orthopedic Manual Surgical Instrument
Stryker GmbH
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
| Date | Apr 17, 2025 (initiated Mar 28, 2025) |
| Status | Open, Classified |
| Reason | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. |
| Root cause | Device Design |
| Action | On March 28, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions needed by Customers and Distributors: Our records indicate that you may have received one or more of the subject devices. It is Stryker's responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. We therefore request that you read this notice carefully and complete the following actions. 1. Immediately check your internal inventory to locate the product(s) listed on the attached Business Reply Form, remove them fro |
| Quantity | 1588 units |
| Distribution | US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.