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Waldemar Link GmbH & Co. KG FDA Inspection Record

FEI 3003386935 · Inspections, Form 483s, warning letters and import refusals

Waldemar Link GmbH & Co. KG is an FDA-registered facility (FEI 3003386935) located in Norderstedt Schleswig-Holstein, DE. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Feb 19, 2026: No Action Indicated (NAI)
Inspections on record
5 (3 VAI, 2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
22, latest Jul 6, 2026
Import refusals
6

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Feb 19, 2026No Action Indicated (NAI)No citations listed
May 11, 2023Voluntary Action Indicated (VAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Sampling plans (21 CFR 820.250(b))
Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g))
Report of violation of the Act (see 803.52(e)(9)) (21 CFR 806.10(a)(2))
and 1 more
Jan 22, 2015Voluntary Action Indicated (VAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Management review - defined interval, sufficient frequency (21 CFR 820.20(c))
Report of Death or Serious Injury (21 CFR 803.50(a)(1))
Jul 26, 2012No Action Indicated (NAI)No citations listed
Sep 16, 2010Voluntary Action Indicated (VAI)Personnel (21 CFR 820.25(a))
Environmental control Lack of or inadequate procedures (21 CFR 820.70(c))

Recalls

Showing the 10 most recent of 22 recalls. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Jul 6, 2026Class IIZ-2934-2026Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating…
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau…
Feb 11, 2026Class IIZ-1651-2026Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; and 1 more product
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments…
Jan 12, 2026Class IIZ-1511-2026Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; and 12 more products
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Nov 10, 2025Class IIZ-0890-2026Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L=…
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the…
Jul 31, 2025Class IIZ-2541-2025LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN…
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Jul 15, 2025Class IIZ-2288-2025Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. and 1 more product
Inconsistent size terminology and color coding used on labeling
Apr 3, 2025Class IIZ-1699-2025Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21… and 3 more products
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Feb 14, 2025Class IIZ-1372-2025Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product… and 2 more products
A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN…
Dec 5, 2024Class IIZ-0769-2025LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L=…
Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further…
May 22, 2024Class IIZ-2410-2024Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01… and 1 more product
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in…

FDA record score

67 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

25 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-2934-2026, this FEI as the recalling firmJul 6, 20264 x 14
Class II recall Z-1651-2026, this FEI as the recalling firmFeb 11, 20264 x 14
Class II recall Z-1511-2026, this FEI as the recalling firmJan 12, 20264 x 14
Class II recall Z-0890-2026, this FEI as the recalling firmNov 10, 20254 x 14
Class II recall Z-2541-2025, this FEI as the recalling firmJul 31, 20254 x 14
Class II recall Z-2288-2025, this FEI as the recalling firmJul 15, 20254 x 14
Class II recall Z-1699-2025, this FEI as the recalling firmApr 3, 20254 x 14
Class II recall Z-1372-2025, this FEI as the recalling firmFeb 14, 20254 x 14
Class II recall Z-0769-2025, this FEI as the recalling firmDec 5, 20244 x 14
Inspection classified VAIMay 11, 20236 x 0.63.6
Class II recall Z-2410-2024, this FEI as the recalling firmMay 22, 20244 x 0.62.4
Class II recall Z-1296-2024, this FEI as the recalling firmFeb 6, 20244 x 0.62.4
Class II recall Z-1257-2024, this FEI as the recalling firmJan 29, 20244 x 0.62.4
Class II recall Z-1219-2024, this FEI as the recalling firmJan 22, 20244 x 0.62.4
Class II recall Z-0749-2024, this FEI as the recalling firmNov 30, 20234 x 0.62.4
Class II recall Z-2481-2023, this FEI as the recalling firmJul 26, 20234 x 0.62.4
Class II recall Z-2641-2023, this FEI as the recalling firmJul 14, 20234 x 0.62.4
Class II recall Z-2345-2023, this FEI as the recalling firmJul 3, 20234 x 0.62.4
Class II recall Z-2066-2023, this FEI as the recalling firmDec 23, 20224 x 0.62.4
Class II recall Z-1377-2022, this FEI as the recalling firmMay 24, 20224 x 0.62.4
Class II recall Z-2046-2023, this FEI as the recalling firmMar 18, 20214 x 0.251
Class II recall Z-0733-2019, this FEI as the recalling firmDec 7, 20184 x 0.251
Class II recall Z-0728-2019, this FEI as the recalling firmDec 4, 20184 x 0.251
Inspection classified VAIJan 22, 201510 years or older, so it adds no points0
Inspection classified VAISep 16, 201010 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Waldemar Link GmbH & Co. KG
Location
Norderstedt Schleswig-Holstein (DE)
Source
device

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.