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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95933

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 05, 2024
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

1 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 1

LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.

Z-0769-2025
Recall number
Z-0769-2025
Initiated
December 05, 2024
Classification
Class II
Status
Ongoing
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).

Code information

UDI-DI: 04026575409785 Serial Numbers: 170418/1971 231113/2472 240219/0512 240311/0727 170515/1335 231113/2473 240219/0513 240311/0729 170717/1773 231113/2474 240219/0514 240311/0730 180219/1681 231113/2475 240219/0515 240311/0731 180219/1687 231113/2476 240219/0516 240311/0732 211122/0489 231113/2478 240219/0518 240311/0733 231113/2462 231113/2479 240219/0519 240311/0734 231113/2463 240219/0505 240219/0520 240311/0735 231113/2464 240219/0506 240219/0521 240311/0736 231113/2465 240219/0507 240219/0522 240311/0737 231113/2466 240219/0508 240219/0523 240311/0738 231113/2467 240219/0509 240219/0524 240311/0739 231113/2468 240219/0510 240219/0525 240311/0740 231113/2469 240219/0511 240219/0526 240311/0741 231113/2470 240311/0742 240311/0726

Distribution pattern

US Nationwide distribution in the states of AL, FL.