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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71526

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

Open FDA event record

Event summary

Timeline bucket
June 03, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
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

2 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 2

Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.

Z-1944-2015
Recall number
Z-1944-2015
Initiated
June 03, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
53 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.

Code information

Part Number: 905620 Lot: 824610

Distribution pattern

Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.

device · product 2 of 2

Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures

Z-1945-2015
Recall number
Z-1945-2015
Initiated
June 03, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
41 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.

Code information

Part Number: 905627 Lot: 753410

Distribution pattern

Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.