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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84151

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

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Event summary

Timeline bucket
February 04, 2019
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

EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096

Z-0611-2020
Recall number
Z-0611-2020
Initiated
February 04, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Encore Medical, Lp
Quantity
410 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long term risks may include an inflammatory response, infection, and/ or pain

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long term risks may include an inflammatory response, infection, and/ or pain

Code information

All Lots

Distribution pattern

CO, WA, CA, UT, CA, TN, TX, MS, MO, AR, OK, LA, MN, IL, IN, KY, OH, MI, PA, SC, FL, PR, AL, GA, NM, AZ, NV, VA, RI, MD, ME PA, NY OUS: None