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U.S. Department of Health and Human Services

Class 2 Device Recall Persona Stemmed Tibial Provisional Size H Right

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 Class 2 Device Recall Persona Stemmed Tibial Provisional Size H Rightsee related information
Date Initiated by FirmAugust 07, 2017
Create DateMay 11, 2018
Recall Status1 Terminated 3 on August 23, 2018
Recall NumberZ-1806-2018
Recall Event ID 79991
510(K)NumberK113369 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductPersona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
Code Information Lot 63683139, UDI (01)00889024246942(10)63683139;  Lot 63613121, UDI (01)00889024246942(10)63613121 
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL)  LOT SPECIFIC" letter dated 8/7/17 to its Customers. The letter described the product, problem and actions to be taken. The Distributors were instructed to: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form and Attachment 3  Certificate of Decontamination to Zimmer Biomet. a. For each return, send a copy of Attachment 1 and Attachment 2 to corporatequality.postmarket@zimmerbiomet.com. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Include a hardcopy of Attachment 2 with returned instruments. Mark the outside of the returned boxes clearly with RECALL. 5. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals that may have received or used the affected product. If there are no additional users to notify, please indicate that no additional users have been identified. 6. Retain a copy of your recall acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 7. If after reviewing this notice you have further questions or concerns please call the customer call center at (574) 371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergen
Quantity in Commerce842 products in total
DistributionWorldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singapore.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JWH
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