| Class 2 Device Recall Biolox Option Taper Sleeve, Type 1 Taper, 6mm Neck | |
Date Initiated by Firm | August 08, 2024 |
Date Posted | September 12, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-3133-2024 |
Recall Event ID |
95231 |
510(K)Number | K082996 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
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Product | Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components.
Item Number: 650-1064 |
Code Information |
UDI: (01)00887868271465(17)331130(10)3185266
Lot Number: 3185266 |
Recalling Firm/ Manufacturer |
Zimmer GmbH Sulzerallee 8 Winterthur Switzerland
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For Additional Information Contact | 411 Technical Services 574-371-3071 |
Manufacturer Reason for Recall | Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6 |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Zimmer issued Urgent Medical Device Recall letter on 8/8/24 to Distributors, Risk Managers and Surgeons. Letter 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 this notice and ensure documentation.
4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall 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 facility s 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.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation.
5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371 |
Quantity in Commerce | 58 units |
Distribution | Worldwide distribution - US Nationwide and the countries of Japan, Netherlands. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = LZO
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