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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72208

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

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Event summary

Timeline bucket
September 15, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Encore Medical, Lp

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

AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of previously failed surgical attempts. Shoulder reconstructive surgery should be reserved for patients who have failed non-operative treatments.

Z-0131-2016
Recall number
Z-0131-2016
Initiated
September 15, 2015
Classification
Class II
Status
Terminated
Recalling firm
Encore Medical, Lp
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.

Code information

Lot: 180052L01

Distribution pattern

US Distribution to states of: PA, FL, ID, and CA.

Field note

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