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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Biomet Vitality Spinal Fixation System

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  Class 2 Device Recall Zimmer Biomet Vitality Spinal Fixation System see related information
Date Initiated by Firm July 30, 2018
Date Posted February 22, 2019
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-0867-2019
Recall Event ID 82076
510(K)Number K171907  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications.
Code Information Item Number; Lot Number; Item Description; UDI #; Manufacturing Quantity   07.02011.001; P141352 (Z00176603); Vitality Shear-off Set Screw; (01)00889024003187 (10)P141352; 2,192 devices  07.02011.001; P141353; Vitality Shear-off Set Screw; (01)00889024003187 (10)P141353; 879 devices  07.02011.001; P141354 (Z00468651); Vitality Shear-off Set Screw; (01) 00889024003187 (10)P141354; 924 devices  07.02011.001; P141358 (Z00420148); Vitality Shear-off Set Screw; (01)00889024003187 (10)P141358; 2,193 devices  07.02011.001; P141359 (Z00274115); Vitality Shear-off Set Screw; (01)00889024003187 (10)P141359; 868 devices  07.02011.001; P141360; Vitality Shear-off Set Screw; (01)00889024003187 (10)P141360; 872 devices  07.02011.001; P142510; Vitality Shear-off Set Screw; (01)00889024003187 (10)P142510; 3,045 devices  07.02011.001; W505611; Vitality Shear-off Set Screw; (01)00889024003187 (10)W505611; 1,545 devices  07.02011.001; W508041; Vitality Shear-off Set Screw; (01)00889024003187 (10)W508041; 1,497 devices  07.02011.001; W509651; Vitality Shear-off Set Screw; (01)00889024003187 (10)W509651; 3,396 devices  07.02011.001; W509661; Vitality Shear-off Set Screw; (01)00889024003187 (10)W509661; 3,382 devices  07.02011.001; W5096619; Vitality Shear-off Set Screw; (01)00889024003187 (10)W5096619; 61 devices  07.02011.001; W526991; Vitality Shear-off Set Screw; (01)00889024003187 (10)W526991; 799 devices  07.02011.001; W529371; Vitality Shear-off Set Screw; (01)00889024003187 (10)W529371; 823 devices  07.02011.001; W530301; Vitality Shear-off Set Screw; (01)00889024003187 (10)W530301; 1,342 devices  07.02011.001; W546001; Vitality Shear-off Set Screw; (01)00889024003187 (10)W546001; 634 devices  07.02011.001; W554821; Vitality Shear-off Set Screw; (01)00889024003187 (10)W554821; 2,110 devices  07.02011.001; W559871; Vitality Shear-off Set Screw; (01)00889024003187 (10)W559871; 1,461 devices  07.02011.001; W573501; Vitality Shear-off Set Screw; (01)00889024003187 (10)W573501; 2,713 devices  07.02011.001; W573511; Vitality Shear-off Set Screw; (01)00889024003187 (10)W573511; 2,698 devices  07.02011.001; W577991; Vitality Shear-off Set Screw; (01)00889024003187 (10)W577991; 2,026 devices W508041 (01)00889024003187 (10)W508041 W509661 (01)00889024003187 (10)W509661 W526991 (01)00889024003187 (10)W526991 W530301 (01)00889024003187 (10)W530301 W554821 (01)00889024003187 (10)W554821 W573501 (01)00889024003187 (10)W573501 W577991 (01)00889024003187 (10)W577991 
Recalling Firm/
Manufacturer		 Zimmer Biomet Spine Inc.
10225 Westmoor Dr
Westminster CO 80021-2702
For Additional Information Contact Kevin W Escapule
574-372-4487
Manufacturer Reason
for Recall		 The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On August 30, 2018 a Urgent Medical Recall notification letter was sent to Distributors and Hospital Risk Managers notifying them of the Zimmer Biomet Vitality¿ Shear-off Set Screw recall. The notification letter described the potential risks associated to the recall and steps they needed to follow to mitigate those potential risk. The responisbilities as described by Zimmer Biomet to the customers is as follows: Your Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. a. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. b. If there are no additional accounts to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. 5. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-447-3625 between 8:00 am and 5:00pm MST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an o
Quantity in Commerce 16,429 devices (Thoracolumbosacral pedicle screw system,Spinal Interlaminal & Spinal Intervertebral Body, both appliances for fixation)
Distribution Distributed Nationwide: AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA and WI.**** International distribution: Australia and EMEA.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = Zimmer Biomet Spine, Inc.
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