FDA Device recall Z-0249-2016

Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon M…

FDA Device
Class II
terminated
Published 2015-11-18

On 2015-11-18 the FDA classified a Class II recall of Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon M… by Stryker Howmedica Osteonics, citing stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may disassociate during use.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0249-2016
Classification	Class II
Status	terminated
Initiated	2015-09-29
Published	2015-11-18
Last updated	2026-09-13 11:53 UTC
Company	Stryker Howmedica Osteonics
Distribution	US

Product

Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal femoral resection in a Triathlon primary MIS TKA. Once the Triathlon MIS distal Resection Guide (cat. no. 6541-5-721/722, for left or right preparation, respectively) has been secured to the femoral, the MIS distal capture can optionally be attached to the distal resection guide to complete the cut, per Trithion MIS surgical protocol TRI ATH-SP-5. Surgical instrument for knee prosthesis implantation.

Reason

Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may disassociate during use.

Identifiers

code_info	Catalog No: 6541-5-723 Lot Nos.: AF1C00, AF1C00A, AF1C00S1, AF1C11, AF1C11A, AF1C11AR, AF1C11AR1, AF1C11J, AF1C11JR, A… Catalog No: 6541-5-723 Lot Nos.: AF1C00, AF1C00A, AF1C00S1, AF1C11, AF1C11A, AF1C11AR, AF1C11AR1, AF1C11J, AF1C11JR, AF1C11M, AF1C11MT, AF1C11X1, AF1C12, AF1C12R, AF1E01, AF1E01D, AF1E01D1, AF1E01D1R, AF1E01M, AF1E01MR, AF1E01MR1, AF1E01MX1, AF1E01MX2, AF1E01MX2R, AF1E01MX3, AF1E01R, AF1E01R1, AF1E07, AF1E08, AF1K14, AF1K14R, AF1T43, AF1W33, AF1W34, AF1W36, AF2C11, AF2C11A, AF2C11G, AF2C11R, AF2C12, AF2C12A, AF2C12A1, AF2C12R, AF2C53, AF2C53A, AF2C58, AF2C58M, AF2C58R, AF2S08, AF3L05, AF3L05P, AF3S11, AF3T02, AF3T02J, AF3V02, AF3V02J, AF3V09, AF3V09A, AF3W04, AF3W04D, AF3W29, AF3W29D, AF3W29X1, AF4C07, AF4C07M, AF4C07P, AF4C07X1, AF5A01, AF5A02, AF5A03, AF5K00, AF5S00, AF5S00T, AF5V01, AF5V01H, AF6E03, AF6E03N, AF6E03T, AF6E03TE, AF6E04, AF6E04J, AF6E04N, AF6K00, AF6K00A, AF6K00D, AF6K00L, AF6K05, AF6K05D, AF6K05H, AF6K05X, AF7A00, AF7A00L, AF7C01. AF7C01E, AF7E00, AF7H01, AF8S00, AF8V03, AF8V03A, AF8W00, AF9E00, AF9L00, AF9L00A, AF9N00, AF9T00, AF9T00E, AFZV06, AFZV18, AFZV18A, AFZV1

code_info

Catalog No: 6541-5-723 Lot Nos.: AF1C00, AF1C00A, AF1C00S1, AF1C11, AF1C11A, AF1C11AR, AF1C11AR1, AF1C11J, AF1C11JR, A…

Catalog No: 6541-5-723 Lot Nos.: AF1C00, AF1C00A, AF1C00S1, AF1C11, AF1C11A, AF1C11AR, AF1C11AR1, AF1C11J, AF1C11JR, AF1C11M, AF1C11MT, AF1C11X1, AF1C12, AF1C12R, AF1E01, AF1E01D, AF1E01D1, AF1E01D1R, AF1E01M, AF1E01MR, AF1E01MR1, AF1E01MX1, AF1E01MX2, AF1E01MX2R, AF1E01MX3, AF1E01R, AF1E01R1, AF1E07, AF1E08, AF1K14, AF1K14R, AF1T43, AF1W33, AF1W34, AF1W36, AF2C11, AF2C11A, AF2C11G, AF2C11R, AF2C12, AF2C12A, AF2C12A1, AF2C12R, AF2C53, AF2C53A, AF2C58, AF2C58M, AF2C58R, AF2S08, AF3L05, AF3L05P, AF3S11, AF3T02, AF3T02J, AF3V02, AF3V02J, AF3V09, AF3V09A, AF3W04, AF3W04D, AF3W29, AF3W29D, AF3W29X1, AF4C07, AF4C07M, AF4C07P, AF4C07X1, AF5A01, AF5A02, AF5A03, AF5K00, AF5S00, AF5S00T, AF5V01, AF5V01H, AF6E03, AF6E03N, AF6E03T, AF6E03TE, AF6E04, AF6E04J, AF6E04N, AF6K00, AF6K00A, AF6K00D, AF6K00L, AF6K05, AF6K05D, AF6K05H, AF6K05X, AF7A00, AF7A00L, AF7C01. AF7C01E, AF7E00, AF7H01, AF8S00, AF8V03, AF8V03A, AF8W00, AF9E00, AF9L00, AF9L00A, AF9N00, AF9T00, AF9T00E, AFZV06, AFZV18, AFZV18A, AFZV1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

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Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0249-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.