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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92500

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 18, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Waldemar Link GmbH & Co. KG (Mfg Site)

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right

Z-2046-2023
Recall number
Z-2046-2023
Initiated
March 18, 2021
Classification
Class II
Status
Ongoing
Quantity
21 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet specifications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm discovered through customer complaints that device segments may not meet specifications.

Code information

Item No. 15-2973/05; UDI-DI: 04026575340699.

Distribution pattern

Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.

device · product 2 of 4

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left

Z-2047-2023
Recall number
Z-2047-2023
Initiated
March 18, 2021
Classification
Class II
Status
Ongoing
Quantity
22 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet specifications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm discovered through customer complaints that device segments may not meet specifications.

Code information

Item No. 15/2973/06; UDI-DI: 04026575340736.

Distribution pattern

Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.

device · product 3 of 4

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right

Z-2048-2023
Recall number
Z-2048-2023
Initiated
March 18, 2021
Classification
Class II
Status
Ongoing
Quantity
16 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet specifications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm discovered through customer complaints that device segments may not meet specifications.

Code information

Item No. 15-2979/01; UDI-DI: 04026575328093.

Distribution pattern

Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.

device · product 4 of 4

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left

Z-2049-2023
Recall number
Z-2049-2023
Initiated
March 18, 2021
Classification
Class II
Status
Ongoing
Quantity
13 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet specifications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm discovered through customer complaints that device segments may not meet specifications.

Code information

Item No. 15-2979/02; UDI-DI: 04026575328109.

Distribution pattern

Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.