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Class 2 Device Recall Biomet |
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Date Initiated by Firm |
May 01, 2020 |
Create Date |
June 12, 2020 |
Recall Status1 |
Terminated 3 on July 28, 2021 |
Recall Number |
Z-2362-2020 |
Recall Event ID |
85641 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product |
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235 |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Biomet 6303 Blue Lagoon Dr Ste 100 Miami FL 33126-6023
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For Additional Information Contact |
411 Technical Services 574-371-3071
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Manufacturer Reason for Recall |
Device and tray that houses the device did not pass steam sterilization process validation testing
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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 |
136 units |
Distribution |
Nationwide
Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND |
Total Product Life Cycle |
TPLC Device Report
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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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