510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-2291-2010

VERSYS HIP SYSTEM FEMORAL HEAD 12/14 TAPER 28 MM DIA. -3.5 MM NECK LENGTH ZIMALOY CO-CR-MO ALLOY STERILE...

Zimmer GmbH / initiated 2010-07-05 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

Zimmer Inc. began a recall of 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... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2291-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
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.
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
Root cause tag
labeling and UDI
FDA root cause
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: [email protected]. 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.
Product codes and lots
VerSys¿ Femoral Head -3.5 x 32 mm Diameter: Catalog number 00-8018-028-01; Lot number 61424803.