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U.S. Department of Health and Human Services

Class 2 Device Recall Persona Anterior Referencing Sizer with Locking Boom

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  Class 2 Device Recall Persona Anterior Referencing Sizer with Locking Boom see related information
Date Initiated by Firm March 10, 2015
Date Posted April 01, 2015
Recall Status1 Terminated 3 on November 06, 2015
Recall Number Z-1360-2015
Recall Event ID 70676
510(K)Number K113369  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom
The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer helps ensure that the desired external rotation is attained and provides a size for the femoral component.
Code Information Part # 42-5099-088-10; Lots: 56573342; 56574505; 56574999; 56574229; 56574818; 56575000; 56574230; 56574819; 56575020; 56574301; 56574820; 56575021; 56574349; 56574861; 56575072; 56574374; 56574862; 56575105; 56574375; 56574863; 56574504; 56574998;
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Kevin W. Escapule
574-372-4487
Manufacturer Reason
for Recall		 Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to print specifications.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Zimmer sent an Urgent Medical device recall letter to all customers on March 10, 2015, via letter and email. The letter identified the product, the problem, and the action to be taken by the customer. Affected units will be inspected. Units that fail inspection will be physically destroyed/scrapped. Units that pass inspection will be re-etched and redistributed. If after reviewing this notification customers have further questions or concerns they were instructed to call the customer call center at 1-877-946-2761. Hours of operation are Monday through Friday, 8:00 a.m. through 5:00 p.m. EST. For questions regarding this recall call 574-372-4487.
Quantity in Commerce 688
Distribution Worldwide Distribution - US including Domestic: Puerto Rico, AZ, NY. OR, ME, NC, OH, TX, CO, IL, TN, PA, HI, CA, KS, WI, VA, MN, NJ, UT, MA, GA, MI, OK, MS, FL, AL, IN, and Internationally to Germany, India, Dominican Republic, Singapore, Korea, Japan, Austrailia, Canada.
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 = JWH and Original Applicant = ZIMMER INC.
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