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 16
Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN 04546540197771; Lot code: K074846
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 2 of 16
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN 04546540199492; Lot code: K081642
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 3 of 16
Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN 04546540199508; Lot code: K0957B1
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 4 of 16
Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN 04546540199775; Lot code: K081650
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 5 of 16
Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN 04546540200105; Lot code: K078C70
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 6 of 16
Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN 04546540200402; Lot code: K08327D
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 7 of 16
Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN: 04546540200655; Lot code: K07AFF5
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 8 of 16
Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN: 04546540200686; Lot code: K076A7C
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 9 of 16
Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN: 04546540200693; Lot code: K08327F
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 10 of 16
Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN: 04546540646583; Lot code: K08D58D
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 11 of 16
Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN: 04546540646842; Lot code: K081650
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 12 of 16
Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN: 04546540647078; Lot code: K078C74
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 13 of 16
Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN: 04546540647320; Lot code: K076A80
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 14 of 16
Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN: 07613252129295; Lot code: K0748D3
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 15 of 16
Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN: 04546540673398; Lot code: K078C7E
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
device · product 16 of 16
Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Code information
GTIN: 04546540673428; Lot code: K081639
Distribution pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
