Device recall: Alloclassic SL Shaft

Class II FDA enforcement event 63103. Recall start date: 4 Sep 2012. Status in the FDA record: Terminated. Termination date: 16 Apr 2014.

Reason for recall, in the words of FDA

Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

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 4 Sep 2012. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 63103 has 40 product records. The first FDA enforcement report date is 14 Nov 2012. The record gives the status Terminated, with the termination date 16 Apr 2014.

FDA enforcement report The 40 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.

Nationwide Distribution.

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

40 product records in the event.

FDA event 63103: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0210-2013	Alloclassic SL Shaft	1355	Class II	Terminated	14 Nov 2012
Z-0211-2013	Biolox delta Ceramic Femoral Head Rx only, sterile	2544	Class II	Terminated	14 Nov 2012
Z-0212-2013	Biolox Option Ceramic Femoral Head System Rx, sterile	88	Class II	Terminated	14 Nov 2012
Z-0213-2013	Wagner SL Revision Stem, uncemented Sterile	87	Class II	Terminated	14 Nov 2012
Z-0214-2013	Alloclassic SL-Offset Stem sterile, Rx	126	Class II	Terminated	14 Nov 2012
Z-0215-2013	Metasul LDH Head Rx Sterile	1739	Class II	Terminated	14 Nov 2012
Z-0216-2013	Metasul Durom Femoral component Sterile, Rx	209	Class II	Terminated	14 Nov 2012
Z-0217-2013	MS-30¿ Stem	30	Class II	Terminated	14 Nov 2012
Z-0218-2013	MS-30¿ Distal centralizer, cemented, sterile, Rx	58	Class II	Terminated	14 Nov 2012
Z-0219-2013	MS-30¿ Proximal positioner	5	Class II	Terminated	14 Nov 2012
Z-0220-2013	Fitmore" Hip Stem	1190	Class II	Terminated	14 Nov 2012
Z-0221-2013	Wagner cone Prosthesis, uncemented, sterile, Rx	56	Class II	Terminated	14 Nov 2012
Z-0222-2013	CoCr Head, sterile, Rx	1000	Class II	Terminated	14 Nov 2012
Z-0223-2013	Anatomical Shoulder" Humeral stem	260	Class II	Terminated	14 Nov 2012
Z-0224-2013	Anatomical Shoulder" Fracture Humeral stem	139	Class II	Terminated	14 Nov 2012
Z-0225-2013	Anatomical Shoulder" Humeral Head	224	Class II	Terminated	14 Nov 2012
Z-0226-2013	zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, Glenoid M, cemented, sterile; REF 01.04214.370, Glenoid L, cemented, sterile; REF 01.04214.400 PE Keeled Glenoid L, cemented, sterile; REF 01.04214.405	164 in USA	Class II	Terminated	14 Nov 2012
Z-0227-2013	Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem	45 USA	Class II	Terminated	14 Nov 2012
Z-0228-2013	Zimmer Inverse/Reverse Screw system,	45 USA	Class II	Terminated	14 Nov 2012
Z-0229-2013	Anatomical Shoulder" Inverse Humeral Cup	66	Class II	Terminated	14 Nov 2012
Z-0230-2013	Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx	228	Class II	Terminated	14 Nov 2012
Z-0231-2013	Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx	74	Class II	Terminated	14 Nov 2012
Z-0232-2013	Anatomical Shoulder" Ball taper for humeral stem	54	Class II	Terminated	14 Nov 2012
Z-0233-2013	Anatomical Shoulder" Fracture Humeral Head	26	Class II	Terminated	14 Nov 2012
Z-0234-2013	CLS Stem	18	Class II	Terminated	14 Nov 2012
Z-0235-2013	Original M.E. Mueller" Low Profile Cup Sterile, Rx	6	Class II	Terminated	14 Nov 2012
Z-0236-2013	Dynesys Set screw M6	58	Class II	Terminated	14 Nov 2012
Z-0237-2013	Dynesys Universal spacer 6-45	5069	Class II	Terminated	14 Nov 2012
Z-0238-2013	Dynesys L.I.S. Stabilizing cord Rx, Sterile	973	Class II	Terminated	14 Nov 2012
Z-0239-2013	Dynesys Revision + set screw	1575	Class II	Terminated	14 Nov 2012
Z-0240-2013	Dynesys HA Pedicle + set screw	1247	Class II	Terminated	14 Nov 2012
Z-0241-2013	DTO" Implant	N/A	Class II	Terminated	14 Nov 2012
Z-0242-2013	Dynesys Top-Loading System Cannulated Pedicle + Set Screw	1406	Class II	Terminated	14 Nov 2012
Z-0243-2013	NCB cancellous screw	2	Class II	Terminated	14 Nov 2012
Z-0244-2013	NCB screw 4.0 self-tapping	41	Class II	Terminated	14 Nov 2012
Z-0245-2013	NCB-PT lateral proximal 3 hole tibial plate	589	Class II	Terminated	14 Nov 2012
Z-0246-2013	NCB-PH Plate	95	Class II	Terminated	14 Nov 2012
Z-0247-2013	Sirus intramedullary nail for tibia, cannulated	195	Class II	Terminated	14 Nov 2012
Z-0248-2013	Kopf Adapter S Sterile, Rx	2011	Class II	Terminated	14 Nov 2012
Z-0249-2013	MS-30 Shaft, Sterile, Rx	13	Class II	Terminated	14 Nov 2012

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 2012: 823
Share of these events in Class II: 88%
Product records in this event: 40Median 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-0210-2013The 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 63103. https://recallregister.com/fda/ii/63103/. 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: Nationwide Distribution.
What quantity of product is in FDA event 63103?: The event has 40 product records. The first record gives this quantity: 1355
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 88% of the 823 device events that started in 2012 are in Class II.