Recall Z-0373-2019 ยท LXH Orthopedic Manual Surgical Instrument
Howmedica Osteonics Corp.
Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee, shoulder, elbow or wrist arthroplasty, or trauma surgeries.
| Date | Nov 2, 2018 (initiated Sep 10, 2018) |
| Status | Terminated |
| Reason | Potential for outer pouch sterile barrier to be compromised |
| Root cause | Under Investigation by firm |
| Action | All affected consignees were notified via 2-day UPS letter (with return receipt). The Urgent Product Recall notice was sent on September 11, 2018 and an updated version dated November 26, 2018 was distributed by Strykers third party recall company Stericycle. Actions to be Taken by Customer: 1. Please inform users of this Urgent Product Recall UPDATE and forward this notice to all those individuals who need to be aware within your organization. 2. Hospitals/Branches/Agencies: Complete and sign the enclosed Recall Notification Business Reply Form and fax a copy to 1-888-312-5960 or email to St |
| Quantity | 15 pouches |
| Distribution | US Nationwide in the states of AL, FL, IL, MI, NJ & OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.