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 22
Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 624820 (01)00887868133732(17)260415(10)624820 867200 (01)00887868133732(17)260731(10)867200
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 2 of 22
Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 624830 (01)00887868133749(17)260414(10)624830 867210 (01)00887868133749(17)260730(10)867210
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 3 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: P0217 (01)00887868135026(10)P0217
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 4 of 22
A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 3286A (01)00887868135033(10)3286A
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 5 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 3287A (01)00887868135071(10)3287A
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 6 of 22
A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: J3835075 (01)00887868131769(17)260722(10)J3835075
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 7 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 054380 (01)00887868134845(17)251111(10)054380
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 8 of 22
A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: RM540H (01)00887868132490(17)260623(10)RM540H
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 9 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: J3853404 (01)00887868134500(17)260813(10)J3853404
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 10 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 429698 (01)00887868151330(10)429698 452448 (01)00887868151330(10)452448
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 11 of 22
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 429698 (01)00887868151347(10)429698 451853 (01)00887868151347(10)451853 462794 (01)00887868151347(10)462794
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 12 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 452448 (01)00887868151354(10)452448 462794 (01)00887868151354(10)462794
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 13 of 22
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: All lots expiring prior to December 31, 2026
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 14 of 22
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 356240 (01)00887868134784(17)270717(10)356240
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 15 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 356270 (01)00887868134821(17)270718(10)356270
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 16 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 356280 (01)00887868134838(17)270716(10)356280; RM256H (01)00887868134838(17)260304(10)RM256H
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 17 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 408870 (01)00887868134920(17)270519(10)408870
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 18 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 408880 (01)00887868134937(17)270517(10)408880
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 19 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: All lots expiring prior to December 31, 2026
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 20 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 408910 (01)00887868134876(17)270519(10)408910
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 21 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 408920 (01)00887868134883(17)270627(10)408920
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
device · product 22 of 22
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Distributed to the field without having completed design history files or design transfer activities
Code information
Lot Number: 356320 (01)00887868134890(17)270720(10)356320
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
