Z-0249-2016Class II

Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot...

Name: Z-0249-2016 Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2015-09-29
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-09-29 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is... on 2015-09-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0249-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-29
Posted: 2015-11-09
Terminated: 2016-09-23
Recalling firm: Howmedica Osteonics Corp
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker notified their Branches/Agencies of this recall by email on September 29, 2015 and notifiction letters and product accountability forms were sent via UPS (with return receipt) on September 29, 2015 to branches and on September 30, 2015 to hospitals. Stericycle wil be handling the returns. Customers with questions were instructed to call 201-831-5826. For questions regarding this recall call 201-831-5272.
Quantity in commerce: 3,444 units
Distribution: Nationwide Distribution including AZ, DE, ID, IL, KS, LA, MI, NH, NM, NJ, NY, OH, PA,TX, VA, VT, WA and WI.
Product codes and lots: 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, AFZV18R, AFZW21, AFZW21A, AFZW22, AFZW23, AFZW23A, AFZW23R, AFZW23R1, AFZW23R2, AFZW23W, AFZW23X1 and AFZW23X1R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0249-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0249-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09

Product code JWH

K123486Class IITriathlon Tritanium Tibial BaseplateStryker / cleared 2013-05-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)