Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica

FDA device recall Z-0373-2019 · posted 2018-11-02 · Terminated

Recall details

Recalling firm

Howmedica Osteonics Corp.

Reason for recall

Potential for outer pouch sterile barrier to be compromised

Action taken

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

Root cause

Under Investigation by firm

Status

Terminated

Product code

LXH

Quantity affected

15 pouches

Distribution

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

Date initiated

2018-09-10

Date posted

2018-11-02

Date terminated

2020-08-31

Location

Mahwah, NJ