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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81513

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

Open FDA event record

Event summary

Timeline bucket
October 24, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer Biomet, Inc.

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

Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma. The Compress¿ Segmental Femoral Replacement System (Short Spindle and Anchor Plug) components are intended for uncemented use only.

Z-0553-2019
Recall number
Z-0553-2019
Initiated
October 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted

Code information

Lot Number: 608740 UDI Number: (01)00880304461666(17)271113(10)608740

Distribution pattern

US Nationwide Distribution in the states of IN, DC, MD