Zimmer, Inc.

⚠️ Moderate Risk

FEI: 1000220733 • Warsaw, IN • UNITED STATES

FEI

FEI Number

1000220733

📍

Location

Warsaw, IN

🇺🇸

Country

UNITED STATES

🏢

Address

1800 W Center St, , Warsaw, IN, United States

Moderate Risk

FDA Import Risk Assessment

35.2

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

10/23/2018

Latest Refusal

12/6/2005

Earliest Refusal

Score Breakdown

Violation Severity

34.0×40%

Refusal Volume

60.9×30%

Recency

0.0×20%

Frequency

33.4×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

34141×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

1183×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

32803×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

Date	Product	Violations	Division
10/23/2018	87HRXARTHROSCOPE AND ACCESSORIES	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
4/20/2016	87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT	118NOT LISTED 3280FRNMFGREG 341REGISTERED	New Orleans District Office (NOL-DO)
10/30/2015	79GFDDERMATOME	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/23/2015	79FSMTRAY, SURGICAL, INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79FSMTRAY, SURGICAL, INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79FSMTRAY, SURGICAL, INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79FSMTRAY, SURGICAL, INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79FSMTRAY, SURGICAL, INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79HTDFORCEPS	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87HWXTAP, BONE	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87HWXTAP, BONE	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79HTDFORCEPS	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87HXXSCREWDRIVER	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87HTJGAUGE, DEPTH	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79HTEELEVATOR	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87HTOREAMER	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79HTRRASP	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79FZYHAMMER, SURGICAL	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79HXLMALLET	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79HXDCLAMP	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87HWJAWL	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87HWAIMPACTOR	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87HWAIMPACTOR	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79FZXGUIDE, SURGICAL, INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79FZXGUIDE, SURGICAL, INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79HWMOSTEOTOME	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87HTOREAMER	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87HWCSCREW, FIXATION, BONE	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	79FSMTRAY, SURGICAL, INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	87HTOREAMER	341REGISTERED	Division of Southeast Imports (DSEI)
12/6/2005	87HWCSCREW, FIXATION, BONE	2480RXPERSONAL 472NO ENGLISH	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Zimmer, Inc.'s FDA import refusal history?

Zimmer, Inc. (FEI: 1000220733) has 43 FDA import refusal record(s) in our database, spanning from 12/6/2005 to 10/23/2018.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Zimmer, Inc.'s FEI number is 1000220733.

What types of violations has Zimmer, Inc. received?

Zimmer, Inc. has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Zimmer, Inc. come from?

All FDA import refusal data for Zimmer, Inc. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.