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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Fluted Headless 1/8 Pin 3.5" Long

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 Class 2 Device Recall Sterile Fluted Headless 1/8 Pin 3.5" Longsee related information
Date Initiated by FirmSeptember 10, 2018
Date PostedNovember 02, 2018
Recall Status1 Terminated 3 on August 31, 2020
Recall NumberZ-0373-2019
Recall Event ID 81192
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductSterile 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.
Code Information Lot SC22130X Exp 2023-08-05
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactLoriann Russo, Sr.
201-831-5000
Manufacturer Reason
for Recall		Potential for outer pouch sterile barrier to be compromised
FDA Determined
Cause 2		Under Investigation by firm
ActionAll 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
Quantity in Commerce15 pouches
DistributionUS Nationwide in the states of AL, FL, IL, MI, NJ & OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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