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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85110

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

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Event summary

Timeline bucket
February 27, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smith & Nephew, Inc.

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

NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins.

Z-1634-2020
Recall number
Z-1634-2020
Initiated
February 27, 2020
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
348 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.

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

Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.

Code information

Component Product Number: PFSR101092; a. Instrument Kit Number: PFSR02050, Lot Numbers 2067, 2212, 3809, 3869, 4354, 5228, 5337, 5494, 5514, 5887, 6248; b. Instrument Kit Number: PFSR02051, Lot Numbers 4354, 5514; c. Instrument Kit Number: PFSR02052, Lot Numbers 4354, 5494, 6248; d. Instrument Kit Number: PFSR02053, Lot Numbers 6248

Distribution pattern

Nationwide distribution to AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, LA, MA, MI, MN, MS, MT, NC, NJ, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV. International distribution to Turkey, United Kingdom, Thailand, Switzerland, France, Australia.