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U.S. Department of Health and Human Services

Class 2 Device Recall Biolox Option Taper Sleeve, Type 1 Taper, 6mm Neck

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 Class 2 Device Recall Biolox Option Taper Sleeve, Type 1 Taper, 6mm Necksee related information
Date Initiated by FirmAugust 08, 2024
Date PostedSeptember 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3133-2024
Recall Event ID 95231
510(K)NumberK082996 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
ProductBiolox 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
For Additional Information Contact411 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
ActionZimmer 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 Commerce58 units
DistributionWorldwide distribution - US Nationwide and the countries of Japan, Netherlands.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LZO
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