Device recall: Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.

Class II FDA enforcement event 66500. Recall start date: 11 Oct 2013. Status in the FDA record: Terminated. Termination date: 14 Apr 2017.

Reason for recall, in the words of FDA

Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged…

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 11 Oct 2013. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 66500 has 44 product records. The first FDA enforcement report date is 26 Feb 2014. The record gives the status Terminated, with the termination date 14 Apr 2017.

FDA enforcement report The 44 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 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg,…

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

44 product records in the event.

FDA event 66500: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1001-2014	Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1002-2014	HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1003-2014	FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1004-2014	Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1005-2014	VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item codes starting with 0011930, 0011931 and 0011941	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1006-2014	VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX STANDARD TUBE, 1 and VERSA-FX SPRCNDLR TUBE, 9 Item codes starting with 001980, 001981, 0011990 and 0011991	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1007-2014	M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1008-2014	RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525.	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1009-2014	INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1010-2014	INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1011-2014	M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543.	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1012-2014	ASIA ONE-PIECE LAG SCREW	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1013-2014	ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50)	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1014-2014	ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1015-2014	DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4.	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1016-2014	MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1017-2014	MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Austin Moore Fem Stem	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1018-2014	MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1019-2014	Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several OD	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1020-2014	NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1021-2014	I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1022-2014	NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NEXGEN PRECOAT STEMMED TI NEXGEN OPTION STEMMED TIB NEXGEN STRAIGHT STEM EXT NEXGEN SHARP FLUTED STEM NEXGEN FLUTED STEM EXT, 1 NEXGEN FLUTED STEM EXT, 2 NEXGEN CEMENTED STEM EXT	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1023-2014	MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1024-2014	TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET SHELL 42MM O TRILOGY ACET SHELL 44MM O TRILOGY ACET SHELL 46MM O TRILOGY ACET SHELL 48MM O TRILOGY ACET SHELL 50MM O TRILOGY ACET SHELL 52MM O TRILOGY ACET SHELL 54MM O TRILOGY ACET SHELL 56MM O TRILOGY ACET SHELL 58MM O…	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1025-2014	HGP II ACETABULAR CUP BON	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1026-2014	HGP II ACETABULAR CUP MOD	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1027-2014	PRESSFIT FEM ST FX 16 X 1	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1028-2014	VERSYS HERITAGE FEM STEM	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1029-2014	12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX ST VERSYS PRESS FIT LD/FX SZ VERSYS ADVOCATE CEMENTED VERSYS ADVOCATE V-LIGN CE VERSYS CEMENTED FEM STEM VERSYS CT FEM STEM 11X120 VERSYS…	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1030-2014	ZIMTRON 6 DEG 22 HEADS	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1031-2014	12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1032-2014	CPT 12/14 COCR (various sizes)	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1033-2014	6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1034-2014	6 DEGREE COCR FEM HEAD 36	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1035-2014	MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1036-2014	CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1037-2014	FEM HD ION (various sizes)	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1038-2014	HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1039-2014	COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1040-2014	PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM PERI. SCR 4.0MM X24MM PERI. SCR 4.0MM X40MM PERI SCR. 4.0MMX14MM FULL PERI SCR. 4.0MMX32MM FULL PERI SCR. 4.0MMX38MM FULL 3.5MM CORT SCR X 10MM 3.5MM CORT SCR X 12MM 3.5MM CORT SCR X 14MM 3.5MM CORT…	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1041-2014	2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2.7 X 12 CORT SCREW/SELFT 2.7 X 14 CORT SCREW/SELFT 2.7 X 16 CORT SCREW/SELFT 2.7 X 18 CORT SCREW/SELFT 2.7 X 20 CORT SCREW/SELFT 2.7 X 22 CORT SCREW/SELFT 2.7 X 24 CORT SCREW/SELFT 2.7 X…	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1042-2014	1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUCI 2.0 X 18 CORT SCREW CRUCI 2.0 X 20 CORT SCREW CRUCI 2.0 X 26 CORT SCREW CRUCI 2.0 X 28 CORT SCREW CRUCI 2.0 X 30 CORT SCREW CRUCI 2.0 X…	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1043-2014	3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE 3.5 COMP PLT, 8 HOLE 3.5 COMP PLT, 9 HOLE 3.5 COMP PLT, 10 HOLE	7,044,680 total	Class II	Terminated	26 Feb 2014
Z-1044-2014	3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3.5 X 20 CORT SCREW SELFT 3.5 X 22 CORT SCREW SELFT 3.5 X 24 CORT SCREW SELFT 3.5 X 26 CORT SCREW SELFT 3.5 X 28 CORT SCREW SELFT 3.5 X 30 CORT SCREW SELFT 3.5 X 32 CORT SCREW SELFT 3.5 X…	7,044,680 total	Class II	Terminated	26 Feb 2014

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: 44Median of the firm: 1
Events of the firm on the register: 108

Other events of the firm

Other FDA enforcement events of Zimmer, Inc.
Initiated	Product (first record)	Type	Class	Records
20 May 2026	Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240	Device	Class II	5
11 May 2026	Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number	Device	Class II	1
30 Mar 2026	Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011	Device	Class II	1
2 Dec 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:	Device	Class II	17
26 Sep 2025	Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Ca	Device	Class II	2
24 Mar 2025	Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constr	Device	Class II	5
27 Feb 2025	NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number	Device	Class II	1
12 Feb 2025	Z1 Femoral Hip System, Product Number 611777612	Device	Class II	1
6 Jan 2025	NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14	Device	Class II	2
17 Sep 2024	Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access fo	Device	Class II	1

Zimmer, Inc.: all 108 events

Official channels

FDA enforcement report Z-1001-2014The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 66500. https://recallregister.com/fda/ii/66500/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

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-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg,…
What quantity of product is in FDA event 66500?: The event has 44 product records. The first record gives this quantity: 7,044,680 total
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.