| | Class 2 Device Recall Zimmer Biomet Vitality Spinal Fixation System |  |
| Date Initiated by Firm | July 30, 2018 |
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| Date Posted | February 22, 2019 |
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| Recall Status1 |
Terminated 3 on April 28, 2021 |
| Recall Number | Z-0868-2019 |
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| Recall Event ID |
82076 |
| 510(K)Number | K150896 |
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| Product Classification |
Appliance, fixation, spinal intervertebral body - Product Code KWQ
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| Product | Vitality Spinal Fixation System.Spinal Intervertebral Body, 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 |
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| 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
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| For Additional Information Contact | Kevin W Escapule
574-372-4487 |
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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 |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| 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 |
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| Quantity in Commerce | 16,429 devices (Thoracolumbosacral pedicle screw system,Spinal Interlaminal & Spinal Intervertebral Body, both appliances for fixation) |
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| 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. |
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| 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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| 510(K) Database | 510(K)s with Product Code = KWQ
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