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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71085

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 04, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Orthopaedics, 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

2 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 2

LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.

Z-1672-2015
Recall number
Z-1672-2015
Initiated
March 04, 2015
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
19,059

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.

Code information

All Lots. Catalog numbers: 129411010 129411020 129411030 129411040 129411050 129411060 129411070 129412010 129412020 129412030 129412040 129412050 129412060 129412070 129495040 129495050 129495060 129496040 129496050 129496060

Distribution pattern

Worldwide Distribution-US (nationwide) and the countries of CANADA, AUSTRALIA, AUSTRIA, BELGIUM, UK, FRANCE, GREECE, IRELAND, ISRAEL, ITALY, KOREA, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, SOUTH AFRICA, SWITZERLAND, THAILAND.

device · product 2 of 2

LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.

Z-1673-2015
Recall number
Z-1673-2015
Initiated
March 04, 2015
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
28,732

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.

Code information

All Lots. Catalog numbers: 129416110 129416112 129416115 129416117 129416120 129416122 129416125 129416210 129416212 129416215 129416217 129416220 129416222 129416225 129416310 129416312 129416315 129416317 129416320 129416322 129416325 129416410 129416412 129416415 129416417 129416420 129416422 129416425 129416510 129416512 129416515 129416517 129416520 129416522 129416525 129416610 129416612 129416615 129416617 129416620 129416622 129416625 129416710 129416712 129416715 129416717 129416720 129416722 129416725 129417110 129417112 129417115 129417117 129417120 129417122 129417125 129417210 129417212 129417215 129417217 129417220 129417222 129417225 129417310 129417312 129417315 129417317 129417320 129417322 129417325 129417410 129417412 129417415 129417417 129417420 129417422 129417425 129417510 129417512 129417515 129417517 129417520 129417522 129417525 129417610 129417612 129417615 129417617 129417620 129417622 129417625 129417710 129417712 129417715 129417717 129417720 129417722 129417725 129495410 129495412 129495415 129495417 129495420 129495510 129495512 129495515 129495517 129495520 129495610 129495612 129495615 129495617 129495620

Distribution pattern

Worldwide Distribution-US (nationwide) and the countries of CANADA, AUSTRALIA, AUSTRIA, BELGIUM, UK, FRANCE, GREECE, IRELAND, ISRAEL, ITALY, KOREA, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, SOUTH AFRICA, SWITZERLAND, THAILAND.