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 Recall Z-0373-2019 · Posted 2018-11-02
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Recalling FirmHowmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2018-09-10
Date Terminated2020-08-31
Product Quantity15 pouches
Reason for Recall
Potential for outer pouch sterile barrier to be compromised
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
[email protected]
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide in the states of AL, FL, IL, MI, NJ & OH.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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