Class 2 Device Recall Versys Beaded Fullcoat Femoral Stem

• Date Initiated by Firm: August 30, 2013
• Date Posted: October 25, 2013
• Recall Status: Terminated on September 25, 2014
• Recall Number: Z-0070-2014
• Recall Event ID: 65799
• 510(K)Number: K953337
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: Versys¿ Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXT; POR FULL-CT FEM ST 12X160MM; VERSYS BEADED FC 12X200MM 8 ST ; POR FULLCT FEM ST 12 LOW EXT; POR FLCT FEM ST 12.0X190 STR; POR FULLCT FEM ST 12 EXT; POR FULL-CT FEM ST LM 12X160MM; POR FULLCT LM FEM ST 12 EXT; POR FULL-CT FEM ST 13X160MM; VERSYS HIP SYSTEM REVISION FEMORAL BEADED FULLCOAT PLUS COLL ; POR FULLCT FEM ST 13 LOW EXT; POR FLCT FEM ST 13.5X190 STR; POR FULLCT FEM ST 13 EXT; POR FULL-CT FEM ST LM 13X160MM; POR FULLCT LM FEM ST 13 EXT; POR FULL-CT FEM ST 14X160MM; VERSYS BEADED FC 14X200MM 8 ST ; POR FULLCT FEM ST 14 LOW EXT; POR FULLCT FEM ST 14 EXT; POR FULL-CT FEM ST LM 14X160MM; POR FULLCT LM FEM ST 14 EXT; POR FULL-CT FEM ST 15X160MM; VERSYS BEADED FC 15X200MM 8 ST ; POR FULLCT FEM ST 15 LOW EXT; POR FLCT FEM ST 15.0X190 STR; POR FLCT FEM ST 15.0X250 STR; POR FULLCT FEM ST 15 EXT; POR FULL-CT FEM ST LM 15X160MM; POR FULLCT FEM ST 15 XEXT; POR FULLCT LM FEM ST 15 EXT; POR FULL-CT FEM ST 16X160MM; VERSYS BEADED FC 16X200MM 8 ST ; POR FULLCT FEM ST 16 LOW EXT; POR FLCT FEM ST 16.5X190 STR; POR FLCT FEM ST 16.5X250 STR; POR FULLCT FEM ST 16 EXT; POR FULL-CT FEM ST LM 16X160MM; POR FULLCT FEM ST 16 XEXT; POR FULLCT LM FEM ST 16 EXT; POR FULL-CT FEM ST 17X160MM; VERSYS BEADED FC 17X200MM 8 ST ; POR FULLCT FEM ST 17 EXT; POR FULL-CT FEM ST LM 17X160MM; POR FULLCT FEM ST 17 XEXT; POR FULLCT LM FEM ST 17 EXT; POR FULL-CT FEM ST 18X160MM; VERSYS BEADED FC 18X200MM 8 ST ; POR FLCT FEM ST 18.0X190 STR; POR FLCT FEM ST 18.0X250 STR; POR FULLCT FEM ST 18 EXT; POR FULL-CT FEM ST LM 18X160MM; POR FULLCT FEM ST 18 XEXT; POR FULLCT LM FEM ST 18 EXT; POR FULL-CT FEM ST 19X160MM; POR FLCT FEM ST 19.5X190 STR; POR FLCT FEM ST 19.5X250 STR; POR FULLCT FEM ST 19 EXT; POR FLCT FEM STEM LM 19X160MM; POR FULLCT FEM ST 19 XEXT; POR FULLCT LM FEM ST 19 EXT; POR FULL-CT FEM ST 20X160MM; VERSYS BEADED FC 20X200MM 8 ST ; POR FULLCT FEM ST 20 EXT; POR FLCT FEM STEM LM 20X160MM; POR FULLCT FEM ST 20 XEXT; POR FULLCT LM FEM ST 20 EXT; POR FULL-CT FEM ST 21X160MM; POR FLCT FEM ST 21.0X190 STR; POR FLCT FEM ST 21.0X250 STR; POR FULLCT FEM ST 21 EXT; POR FLCT FEM STEM LM 21X160MM; POR FULLCT FEM ST 21 XEXT; POR FULLCT LM FEM ST 21 EXT; POR FULLCT FEM STEM 22X160MM; POR FLCT FEM ST 22.5X190 STR; POR FLCT FEM ST 22.5X250 STR; POR FULLCT FEM ST 22 EXT; POR FLCT FEM STEM LM 22X160MM; POR FULLCT FEM ST 22 XEXT; POR FULLCT LM FEM ST 22 EXT.; ; Used in total hip replacement.
• Code Information: Part Number Range: 00-7843-011/022-06/56
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-613-6131
• Manufacturer Reason for Recall: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
• FDA Determined Cause: Package design/selection
• Action: August 30, 2013 Urgent Recall Notices were sent to Distributors, hospital risk managers and surgeons identifying the issue and directing consignees to make all affected personnel aware of the contents of the notification. The notice identified the products involved, the issue, possible adverse events associated with the issue and recommended that implants found with LDPE bag adhesion not use the product and return it to Zimmer sales representatives. Questions or concerns should be addressed to Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST.
• Quantity in Commerce: 6380
• Distribution: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
• 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.