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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96386

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

Open FDA event record

Event summary

Timeline bucket
February 14, 2025
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

3 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 3

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

Z-1372-2025
Recall number
Z-1372-2025
Initiated
February 14, 2025
Classification
Class II
Status
Ongoing
Quantity
37 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label because of an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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 for a different product.

Code information

Product Code: 880-601/11; UDI-DI: 04026575443925; Lot Numbers: 1943294, 1943296, 1943297, 2049174.

Distribution pattern

Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.

device · product 2 of 3

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12

Z-1373-2025
Recall number
Z-1373-2025
Initiated
February 14, 2025
Classification
Class II
Status
Ongoing
Quantity
52 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label because of an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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 for a different product.

Code information

Product Code: 880-601/12; UDI-DI: 04026575443932; Lot Numbers: 1943274, 1943276, 2049172, 2049173, 2049175.

Distribution pattern

Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.

device · product 3 of 3

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13

Z-1374-2025
Recall number
Z-1374-2025
Initiated
February 14, 2025
Classification
Class II
Status
Ongoing
Quantity
20 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label because of an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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 for a different product.

Code information

Product Code: 880-601/13; UDI-DI: 04026575443949; Lot Numbers: 1943277, 1943280.

Distribution pattern

Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.