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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88510

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

Open FDA event record

Event summary

Timeline bucket
August 18, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
In2bones USA, LLC

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

CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures.

Z-2506-2021
Recall number
Z-2506-2021
Initiated
August 18, 2021
Classification
Class II
Status
Terminated
Recalling firm
In2bones USA, LLC
Quantity
835 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.

Code information

Lot Numbers: 992921, 1018971, 1046581, and 1070081.

Distribution pattern

US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, LA, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, VA, and WI. There was no military/government distribution.