—#167745

Product

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot SC22130X Exp 2023-08-05

Why it was recalled

Potential for outer pouch sterile barrier to be compromised

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 Strykerortho5807@stericycle.com

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: US Nationwide in the states of AL, FL, IL, MI, NJ & OH.

Timeline

Recall initiated: 2018-09-10
Posted by FDA: 2018-11-02
Terminated: 2020-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167745. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.