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U.S. Department of Health and Human Services

Class 2 Device Recall VerSys Femoral Head

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  Class 2 Device Recall VerSys Femoral Head see related information
Date Initiated by Firm July 05, 2010
Date Posted August 26, 2010
Recall Status1 Terminated 3 on January 12, 2011
Recall Number Z-2291-2010
Recall Event ID 56032
510(K)Number K953337  
Product Classification prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product VERSYS¿ HIP SYSTEM
FEMORAL HEAD 12/14 TAPER 28 MM DIA. -3.5 MM NECK LENGTH
ZIMALOY¿ CO-CR-MO ALLOY STERILE QTY-1
MANUFACTURED BY ZIMMER MANUFACTURING B.V.,
A SUBSIDIARY OF ZIMMER, INC. (WARSAW, IN)

The VerSys¿ Hip System Femoral Heads are intended for use in total hip arthroplasty and are assembled onto the proximal taper of the hip stem. The femoral heads manufactured from Zimaloy Alloy are intended for mating with Tivanium" Ti-6AL-4V Alloy and Zimaloy Alloy femoral stems equipped with taper necks. These femoral heads are available in two Morse-type taper options, 6-degree and 12/14, each of which mates with the corresponding 6 degree or 12/14 taper of a femoral stem prosthesis. Each taper option is supplied in a variety of diameters and neck lengths for use in total hip arthroplasty.
Code Information VerSys¿ Femoral Head -3.5 x 32 mm Diameter: Catalog number 00-8018-028-01; Lot number 61424803.
Recalling Firm/
Manufacturer		 Zimmer Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
574-372-4463
Manufacturer Reason
for Recall		 Zimmer, Inc. has determined that there is a potential for a package to be labeled as a 28 mm femoral head but contain a 32 mm femoral head. In addition, there is a potential for the patient record label to be incorrect.
FDA Determined
Cause 2		 Other
Action The firm, Zimmer, Inc., sent an "URGENT: DEVICE REMOVAL" letter dated July 9, 2010, to all consignees. The letter described the issue, clinical implications, affected product, and required actions. The consignees were instructed to carefully review the letter, ensure users of the VerSys Hip System Femoral Head device at their faculty have been informed of this removal and perform a physical count of all affected product at their facility, record the data on the Inventory Return Certification Form and/or the User Facility/HCP Form and return the form via fax at (574) 372-4265 or email: aimee.wood@zimmer.com. Zimmer Inc. will conduct a removal of all remaining (unused) units of the subject lots. For shipping assistance, questions or assistance in notifying your accounts about the device removal, please contact Zimmer, Inc. at 1-800-613-6131 or 574-372-4463.
Quantity in Commerce 103
Distribution Worldwide distribution: USA and countries including Bolivia, Canada, New Zealand, Taiwan, Thailand, Singapore, and India.
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 = LPH and Original Applicant = ZIMMER, INC.
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