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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71171

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

Open FDA event record

Event summary

Timeline bucket
April 16, 2015
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Biomet, 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

4 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 4

Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.

Z-1754-2015
Recall number
Z-1754-2015
Initiated
April 16, 2015
Classification
Class III
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
1315

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling contains incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

Code information

Part Numbers: 11-104212 & 11-104211;Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650.

Distribution pattern

Worldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan, Chile, Korea, Mexico, New Zealand, Trinidad/Tobago, Thailand, Argentina, Australia, and China.

device · product 2 of 4

Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.

Z-1755-2015
Recall number
Z-1755-2015
Initiated
April 16, 2015
Classification
Class III
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
2

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling contains incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

Code information

Part Numbers: 113644; Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650.

Distribution pattern

Worldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan, Chile, Korea, Mexico, New Zealand, Trinidad/Tobago, Thailand, Argentina, Australia, and China.

device · product 3 of 4

MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.

Z-1756-2015
Recall number
Z-1756-2015
Initiated
April 16, 2015
Classification
Class III
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
1315

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling contains incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

Code information

Part Numbers: 141314; 141316; 141318; 141320; Use-by 2025-03-13; Lot Numbers: 035650; 035690; 065500; 066850; 066900; 066910; 066930; 066940; 066950; 066960; 066970; 066990; 067010; 104580; 104590; 104600; 104620; 104630; 104640; 104650; 104660; 125820; 125830; 125840; 129180; 183220; 183230; 183240; 183250; 183260; 183270; 183280; 183290; 183300; 183310; 183320; 257770; 257780; 257790; 257810; 257850; 257860; 257870; 257880; 299730; 299750; 299760; 299780; 299800; 299810; 299820; 842220; 951620; 954160; 997470; 023580; 077970; 125850; 251680; 335490; 997510; 997520; 997530; 997540; 078000; 078020; 104230; 125860; 251710; 335510; 997550; 997560; 997570; 078030; 104240; 114930; 333940; 529710; 997590

Distribution pattern

Worldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan, Chile, Korea, Mexico, New Zealand, Trinidad/Tobago, Thailand, Argentina, Australia, and China.

device · product 4 of 4

Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.

Z-1757-2015
Recall number
Z-1757-2015
Initiated
April 16, 2015
Classification
Class III
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
1315

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling contains incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

Code information

Part Numbers: 163667; 163668; 163669; 163670; 163674; Use-by 2025-03-18; Lot Numbers: 331620; 331650; 453080; 453090; 453110; 453120; 489140; 453180; 471380; 471410; 044600; 332720; 375590; 375620; 375630; 375640; 375650; 465840; 466050; 470060; 471430; 471440; 471450; 375660; 375670; 375700; 453220

Distribution pattern

Worldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan, Chile, Korea, Mexico, New Zealand, Trinidad/Tobago, Thailand, Argentina, Australia, and China.