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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72960

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

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Event summary

Timeline bucket
January 04, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Otto Bock Healthcare GmbH

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

Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.

Z-0608-2016
Recall number
Z-0608-2016
Initiated
January 04, 2016
Classification
Class II
Status
Terminated
Recalling firm
Otto Bock Healthcare GmbH
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error where the wrong Loctite was used during repair.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error where the wrong Loctite was used during repair.

Code information

All serviced between 27 April 2015 and 17 November 2015

Distribution pattern

Nationwide Distribution.