CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report

Biolox¿ delta Ceramic Femoral Head recalled by Zimmer

Zimmer is recalling Biolox¿ delta Ceramic Femoral Head, distributed nationwide in the US. The recall was initiated on 4 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF Numbers: 00-8775-028-01, 00-8775-028-02, 00-8775-028-03, 00-8775-032-01, 00-8775-032-02, 00-8775-032-03, 00-8775-032-04, 00-8775-036-01, 00-8775-036-02, 00-8775-036-03, 00-8775-036-04, 00-8775-040-01, 00-8775-040-02, 00-8775-040-03, and 00-8775-040-04.

Quantity recalled2544

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0211-2013
FDA event ID: 63103
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 4 Sep 2012
FDA classified: 6 Nov 2012
Reported: 14 Nov 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

4 Sep 2012	Recall initiated by company
6 Nov 2012	Classified by FDA	+63 days
14 Nov 2012	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Biolox¿ delta Ceramic Femoral Head Rx only, sterile

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

REF Numbers: 00-8775-028-01, 00-8775-028-02, 00-8775-028-03, 00-8775-032-01, 00-8775-032-02, 00-8775-032-03, 00-8775-032-04, 00-8775-036-01, 00-8775-036-02, 00-8775-036-03, 00-8775-036-04, 00-8775-040-01, 00-8775-040-02, 00-8775-040-03, and 00-8775-040-04.

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

39 other products · FDA event 63103

This product is part of a recall event; the main page for the event is Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw recalled.

Reported	Class	Recall	Company	Reason	Where
14 Nov 2012	CLASS II	Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw recalled	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	NCB¿ screw ¿ 4.0 self-tapping recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	DTO" Implant recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Anatomical Shoulder" Fracture Humeral stem recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Alloclassic SL Shaft recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx recalled	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Biolox¿ Option Ceramic Femoral Head System Rx, sterile recalled	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Anatomical Shoulder Glenoid S, cemented, sterile recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Anatomical Shoulder" Inverse Humeral Cup recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx recalled	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Dynesys¿ Revision + set screw recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	MS-30¿ Stem recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Anatomical Shoulder" Humeral stem recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	MS-30¿ Distal centralizer, cemented, sterile, Rx recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	CLS Stem recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Original M.E recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Anatomical Shoulder" Humeral Head recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	NCB¿ cancellous screw recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Kopf Adapter S Sterile, Rx recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Fitmore" Hip Stem recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Dynesys¿ HA Pedicle + set screw recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	NCB¿-PH Plate recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Metasul¿ Durom¿ Femoral component Sterile, Rx recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Dynesys¿ Set screw M6 recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Dynesys¿ Universal spacer recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	NCB¿-PT lateral proximal 3 hole tibial plate recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Dynesys¿ L.I.S recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Sirus¿ intramedullary nail for tibia, cannulated ¿ recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Alloclassic¿ SL-Offset Stem sterile, Rx recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Wagner SL Revision Stem, uncemented Sterile recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Wagner cone Prosthesis, uncemented, sterile, Rx recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	CoCr Head, sterile, Rx recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	MS-30¿ Proximal positioner recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Anatomical Shoulder" Fracture Humeral Head recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Metasul¿ LDH¿ Head Rx Sterile recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Anatomical Shoulder" Revision Humeral stem recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	MS-30 Shaft, Sterile, Rx recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Inverse/Reverse Screw system recalled by Zimmer	Zimmer	Other	Nationwide
14 Nov 2012	CLASS II	Anatomical Shoulder" Ball taper for humeral stem recalled by Zimmer	Zimmer	Other	Nationwide

More recalls from Zimmer

All 539

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Device	CLASS II	Off-Axis Comprehensive Shoulder System, Large, Augment recalled	Zimmer	Foreign Material	Nationwide
1 Jul 2026Device	CLASS II	Off-Axis Comprehensive Shoulder System Small, Augment recalled by Zimmer	Zimmer	Foreign Material	Nationwide
1 Jul 2026Device	CLASS II	Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide recalled	Zimmer	Foreign Material	Nationwide
1 Jul 2026Device	CLASS II	Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment recalled	Zimmer	Packaging Defects	IN
1 Jul 2026Device	CLASS II	Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide recalled	Zimmer	Foreign Material	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide