Medium RiskFDA Device

Stryker GmbH: 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.

Agency Publication Date: July 10, 2018

Affected Products

Product: Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S

GTIN 04546540197771; Lot code: K074846

Lot Numbers:

code

Product: Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S

GTIN 04546540199492; Lot code: K081642

Lot Numbers:

code

Product: Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S

GTIN 04546540199508; Lot code: K0957B1

Lot Numbers:

code

Product: Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S

GTIN 04546540199775; Lot code: K081650

Lot Numbers:

code

Product: Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S

GTIN 04546540200105; Lot code: K078C70

Lot Numbers:

code

Product: Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S

GTIN 04546540200402; Lot code: K08327D

Lot Numbers:

code

Product: Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S

GTIN: 04546540200655; Lot code: K07AFF5

Lot Numbers:

code

Product: Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S

GTIN: 04546540200686; Lot code: K076A7C

Lot Numbers:

code

Product: Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S

GTIN: 04546540200693; Lot code: K08327F

Lot Numbers:

code

Product: Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S

GTIN: 04546540646583; Lot code: K08D58D

Lot Numbers:

code

Product: Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S

GTIN: 04546540646842; Lot code: K081650

Lot Numbers:

code

Product: Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S

GTIN: 04546540647078; Lot code: K078C74

Lot Numbers:

code

Product: Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S

GTIN: 04546540647320; Lot code: K076A80

Lot Numbers:

code

Product: Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S

GTIN: 07613252129295; Lot code: K0748D3

Lot Numbers:

code

Product: Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S

GTIN: 04546540673398; Lot code: K078C7E

Lot Numbers:

code

Product: Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S

GTIN: 04546540673428; Lot code: K081639

Lot Numbers:

code

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80131

Status: Resolved

Manufacturer: Stryker GmbH

Manufactured In: Switzerland

Units Affected: 6 products (12; 2; 17; 9; 1; 7)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S

GTIN 04546540197771; Lot code: K074846

Lot Numbers:

code

Product: Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S

GTIN 04546540199492; Lot code: K081642

Lot Numbers:

code

Product: Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S

GTIN 04546540199508; Lot code: K0957B1

Lot Numbers:

code

Product: Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S

GTIN 04546540199775; Lot code: K081650

Lot Numbers:

code

Product: Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S

GTIN 04546540200105; Lot code: K078C70

Lot Numbers:

code

Product: Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S

GTIN 04546540200402; Lot code: K08327D

Lot Numbers:

code

Product: Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S

GTIN: 04546540200655; Lot code: K07AFF5

Lot Numbers:

code

Product: Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S

GTIN: 04546540200686; Lot code: K076A7C

Lot Numbers:

code

Product: Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S

GTIN: 04546540200693; Lot code: K08327F

Lot Numbers:

code

Product: Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S

GTIN: 04546540646583; Lot code: K08D58D

Lot Numbers:

code

Product: Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S

GTIN: 04546540646842; Lot code: K081650

Lot Numbers:

code

Product: Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S

GTIN: 04546540647078; Lot code: K078C74

Lot Numbers:

code

Product: Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S

GTIN: 04546540647320; Lot code: K076A80

Lot Numbers:

code

Product: Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S

GTIN: 07613252129295; Lot code: K0748D3

Lot Numbers:

code

Product: Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S

GTIN: 04546540673398; Lot code: K078C7E

Lot Numbers:

code

Product: Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S

GTIN: 04546540673428; Lot code: K081639

Lot Numbers:

code