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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85211

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

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Event summary

Timeline bucket
July 10, 2018
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.

Z-1692-2020
Recall number
Z-1692-2020
Initiated
July 10, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Encore Medical, LP
Quantity
28 (14 REF S200635 and 14 S200636)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The retaining ring on the neck trials has a potential to fail interoperatively.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The retaining ring on the neck trials has a potential to fail interoperatively.

Code information

All Revision C trials. REF S-2000635: 313R1000, 313R1900, 313R1901; REF S-200636: 314R1000, 314R1900, 314R1901.

Distribution pattern

Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.