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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88812

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

Open FDA event record

Event summary

Timeline bucket
October 01, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Limacorporate S.p.A

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

REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852

Z-0159-2022
Recall number
Z-0159-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Recalling firm
Limacorporate S.p.A
Quantity
151 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.

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

There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.

Code information

2103525

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of CA, FL, MO, KS, CO, TX, KS, IL, PA, NY, NC, MI, MA, OK and the countries of Austria, Croatia, Germany, Ireland, Italy, Japan, Korea, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden.

device · product 2 of 2

REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845

Z-0160-2022
Recall number
Z-0160-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Recalling firm
Limacorporate S.p.A
Quantity
200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.

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

There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.

Code information

2103825

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of CA, FL, MO, KS, CO, TX, KS, IL, PA, NY, NC, MI, MA, OK and the countries of Austria, Croatia, Germany, Ireland, Italy, Japan, Korea, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden.