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.
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
Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
These labels are deterministic app interpretations, not FDA categories.
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
Code information
lot 276760
Distribution pattern
Worldwide Distribution: US (nationwide) in states of: AL, AR, FL, GA, IN, KY, LA, MO, MS, OH, OK, TX, and VA; and countries of: Canada, Costa Rica and Chile.
device · product 2 of 2
Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
These labels are deterministic app interpretations, not FDA categories.
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
Code information
lot 299340
Distribution pattern
Worldwide Distribution: US (nationwide) in states of: AL, AR, FL, GA, IN, KY, LA, MO, MS, OH, OK, TX, and VA; and countries of: Canada, Costa Rica and Chile.
