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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet

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  Class 2 Device Recall Biomet see related information
Date Initiated by Firm May 01, 2020
Create Date June 12, 2020
Recall Status1 Terminated 3 on July 28, 2021
Recall Number Z-2363-2020
Recall Event ID 85641
Product Classification unknown device name - Product Code N/A
Product Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray
Product Code: 246111003
Code Information All lots
Recalling Firm/
Manufacturer		 Biomet
6303 Blue Lagoon Dr Ste 100
Miami FL 33126-6023
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 Device and tray that houses the device did not pass steam sterilization process validation testing
FDA Determined
Cause 2		 Process design
Action Zimmer Biomet issued letter dated 5/1/20 to Distributors,Risk Managers and Surgeons, states reason for recall, health risk and action to take: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the recall notice for hospitals and ensure documentation. 4. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule Distributor Responsibilities: Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 1. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
Quantity in Commerce 705 units
Distribution Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND
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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