Stryker GmbH: Seal integrity of the blister pack may be compromised and sterility cannot be assured

Agency Publication Date: June 16, 2020

Affected Products

Product: Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K01CF9F

Lot Numbers:

Number

Product: Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K0207C2

Lot Numbers:

Number

Product: Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K0207B0, K02C1A8, K02C1A9, K0302E4

Lot Numbers:

Number

Product: Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K02AE3F, K02C191, K02C1AA, K0302F9, K0302FA, K0302FD, K030307, K030313, K030315, K030EE3, K030EE4, K030EE5, K030EE8, K031B63, K032879, K0E902D, K0E9086, K0E90B7, K0E90BB, K0EAC03

Lot Numbers:

Number

Product: Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K029C38, K029C39, K030EF6, K030EF7, K030EF9, K031B66

Lot Numbers:

Number

Product: Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K0207B3, K031B6B, K031B6C, K033439

Lot Numbers:

Number

Product: Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K02C1BB, K03033E, K030342, K03035D, K030F17, K030F1D, K031B6E, K031B70, K0328A5

Lot Numbers:

Number

Product: Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K030F1E, K033442

Lot Numbers:

Number

Product: Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K03A7FF

Lot Numbers:

Number

Product: Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K037E2D

Lot Numbers:

Number

Product: Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K0386FB

Lot Numbers:

Number

Product: Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K020791

Lot Numbers:

Number

Product: Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K020795, K020796

Lot Numbers:

Number

Product: Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K020793, K020794

Lot Numbers:

Number

Product: Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K02803B

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85681

Status: Resolved

Manufacturer: Stryker GmbH

Manufactured In: Switzerland

Units Affected: 15 products (56 OUS; 26 OUS; 186 OUS; 109 OUS; 69 OUS; US 3; OUS 2; US 3; OUS 13; OUS 40; US 46; OUS 314; OUS: 1404; US 76; OUS 290; OUS 400; US:127; OUS 454; OUS 121; US 3; OUS 1)

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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

Lot Number: K01CF9F

Lot Numbers:

Number

Lot Number: K0207C2

Lot Numbers:

Number

Lot Number: K0207B0, K02C1A8, K02C1A9, K0302E4

Lot Numbers:

Number

Lot Number: K02AE3F, K02C191, K02C1AA, K0302F9, K0302FA, K0302FD, K030307, K030313, K030315, K030EE3, K030EE4, K030EE5, K030EE8, K031B63, K032879, K0E902D, K0E9086, K0E90B7, K0E90BB, K0EAC03

Lot Numbers:

Number

Lot Number: K029C38, K029C39, K030EF6, K030EF7, K030EF9, K031B66

Lot Numbers:

Number

Lot Number: K0207B3, K031B6B, K031B6C, K033439

Lot Numbers:

Number

Lot Number: K02C1BB, K03033E, K030342, K03035D, K030F17, K030F1D, K031B6E, K031B70, K0328A5

Lot Numbers:

Number

Lot Number: K030F1E, K033442

Lot Numbers:

Number

Product: Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K03A7FF

Lot Numbers:

Number

Lot Number: K037E2D

Lot Numbers:

Number

Lot Number: K0386FB

Lot Numbers:

Number

Lot Number: K020791

Lot Numbers:

Number

Product: Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Lot Number: K020795, K020796

Lot Numbers:

Number

Lot Number: K020793, K020794

Lot Numbers:

Number

Lot Number: K02803B

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85681

Status: Resolved

Manufacturer: Stryker GmbH

Manufactured In: Switzerland

Units Affected: 15 products (56 OUS; 26 OUS; 186 OUS; 109 OUS; 69 OUS; US 3; OUS 2; US 3; OUS 13; OUS 40; US 46; OUS 314; OUS: 1404; US 76; OUS 290; OUS 400; US:127; OUS 454; OUS 121; US 3; OUS 1)