Skip to content

Medical device manufacturer

Zimmer, Inc.

Zimmer, Inc. holds 422 FDA 510(k) clearances across 79 product codes. Median elapsed review time is 86 days. openFDA lists 1,073 recall records naming the company. FDA publishes it under 15 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
422
Product codes
79
Median review
86 days
Recall records
1,073

How does FDA spell Zimmer, Inc.?

FDA publishes this company under 15 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
ZIMMER GMBHdevice/registrationlistingnormalised
ZIMMER PTE. LTD.device/registrationlistingnormalised
ZIMMER, INC.device/registrationlistingnormalised
Zimmerdevice/510knormalised
Zimmer GmbHdevice/510knormalised
Zimmer GmbHdevice/enforcementnormalised
Zimmer GmbHdevice/recallnormalised
Zimmer Gmbhdevice/enforcementnormalised

Showing 8 of 15.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Zimmer, Inc. file in?

79 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5190 days
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented4697 days
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3484 days
HRSPlate, Fixation, Bone3244 days
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2778 days
HSBRod, Fixation, Intramedullary And Accessories2386 days
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer1989 days
HWCScrew, Fixation, Bone1269 days
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1088 days
PHXShoulder Prosthesis, Reverse Configuration1066 days
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer988 days
KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)989 days
JDCProsthesis, Elbow, Constrained, Cemented888 days
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented888 days
KWPAppliance, Fixation, Spinal Interlaminal732 days
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented789 days
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer688 days
HAWNeurological Stereotaxic Instrument5135 days
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented556 days
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented5123 days
GEIElectrosurgical, Cutting & Coagulation & Accessories451 days
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer4159 days
FRNPump, Infusion265 days
FYAGown, Surgical229 days
HRXArthroscope210 days

Showing the 25 they file in most, of 79.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Zimmer, Inc. had a recall?

openFDA lists 1,073 recall records naming this company across its whole history, of which 26 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.

  • Z-2527-2026Class IIOpen, ClassifiedPHX

    Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

  • Z-2528-2026Class IIOpen, ClassifiedPHX

    Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

  • Z-2529-2026Class IIOpen, ClassifiedPHX

    Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

  • Z-2530-2026Class IIOpen, ClassifiedPHX

    Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

  • Z-2531-2026Class IIOpen, ClassifiedPHX

    Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Showing the 5 most recently initiated of 1,073.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Zimmer, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K261683Augment Off-Axis Instrument SystemPHX26
K260831Z1 Hip SystemLZO95
K251840Zimmer® Persona® Personalized Knee SystemMBH346
K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemLZO96
K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)MBF147
K253566Affixus Retrograde Femoral Nailing SystemHSB115
K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH164
K252623G7® Revision Acetabular SystemLPH169
K251098Identity Revision Humeral StemsMBF123
K251906Z1 Hip SystemLZO28

Source: openFDA device/510k · retrieved

Where is Zimmer, Inc. registered?

FDA lists 3 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.

Watch what Zimmer, Inc. files next

Get an email when this company clears a new device, or when anything is recalled in a product code you follow.

Start watching with DeviceSignal

Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.