Recall Register

Device recall: Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.

Class II FDA enforcement event 65799. Recall start date: . Status in the FDA record: Terminated. Termination date: .

Reason for recall, in the words of FDA

The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Zimmer, Inc. started this device recall on 30 Aug 2013. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 65799 has 13 product records. The first FDA enforcement report date is 6 Nov 2013. The record gives the status Terminated, with the termination date 25 Sep 2014.

FDA enforcement reportThe 13 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany,…

Recalling firm

Zimmer, Inc., Warsaw, IN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

13 product records in the event.

FDA event 65799: product records
Recall numberProductQuantityClassStatusReport date
Z-0068-2014Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.72806Class IITerminated6 Nov 2013
Z-0069-2014CPT Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14 SIZE 3 COCR EXT; CPT 12/14 SZ 3 COCR…24561Class IITerminated6 Nov 2013
Z-0070-2014Versys 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…6380Class IITerminated6 Nov 2013
Z-0071-2014Metasul Head. Intended for use either with or without bone cement in total hip arthroplasty.194 (8770-040)Class IITerminated6 Nov 2013
Z-0072-2014CoCr Head (Not distributed in the United States) Used in total hip replacement.604064 totalClass IITerminated6 Nov 2013
Z-0073-2014NexGen Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R…604064 totalClass IITerminated6 Nov 2013
Z-0074-2014NexGen Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF POR FEM, D-R CR-FLEX GSF POR FEM, D-L MINUS; CR-FLEX GSF POR FEM, D-R MINUS CR-FLEX GSF POR FEM, E-L; CR-FLEX GSF POR FEM, E-R; CR-FLEX…11694Class IITerminated6 Nov 2013
Z-0075-2014Natural-Knee Flex Femoral Component. Provides increased flexion capability.33987Class IITerminated6 Nov 2013
Z-0076-2014Zimmer Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint.32537Class IITerminated6 Nov 2013
Z-0077-2014Gender Solutions" Patello-Femoral Component5103Class IITerminated6 Nov 2013
Z-0078-2014Natural-Knee II Femoral Component13483Class IITerminated6 Nov 2013
Z-0079-2014Sidus" Head (Not distributed in the United States)0 in USAClass IITerminated6 Nov 2013
Z-0080-2014NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)3475Class IITerminated6 Nov 2013

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2013
1,236
Share of these events in Class II
90%
Product records in this event
13Median of the firm: 1
Events of the firm on the register
108

Other events of the firm

Other FDA enforcement events of Zimmer, Inc.
InitiatedProduct (first record)TypeClassRecords
20 May 2026Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240DeviceClass II5
11 May 2026Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog NumberDeviceClass II1
30 Mar 2026Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011DeviceClass II1
2 Dec 2025Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:DeviceClass II17
26 Sep 2025Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/CaDeviceClass II2
24 Mar 2025Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-ConstrDeviceClass II5
27 Feb 2025NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model NumberDeviceClass II1
12 Feb 2025Z1 Femoral Hip System, Product Number 611777612DeviceClass II1
6 Jan 2025NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14DeviceClass II2
17 Sep 2024Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access foDeviceClass II1

Zimmer, Inc.: all 108 events

Official channels

Cite this page

Recall Register. FDA enforcement event 65799. https://recallregister.com/fda/ii/65799/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA device enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany,…
What quantity of product is in FDA event 65799?
The event has 13 product records. The first record gives this quantity: 72806
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?
90% of the 1,236 device events that started in 2013 are in Class II.