Reported Nov 18, 2015 · Terminated
Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205,…
Stryker Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- 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.
- Lot codes and dates
- Catalog No
119 of 119 codes
6541-5-723 Lot Nos.: AF1C00AF1C00AAF1C00S1AF1C11AF1C11AAF1C11ARAF1C11AR1AF1C11JAF1C11JRAF1C11MAF1C11MTAF1C11X1AF1C12AF1C12RAF1E01AF1E01DAF1E01D1AF1E01D1RAF1E01MAF1E01MRAF1E01MR1AF1E01MX1AF1E01MX2AF1E01MX2RAF1E01MX3AF1E01RAF1E01R1AF1E07AF1E08AF1K14AF1K14RAF1T43AF1W33AF1W34AF1W36AF2C11AF2C11AAF2C11GAF2C11RAF2C12AF2C12AAF2C12A1AF2C12RAF2C53AF2C53AAF2C58AF2C58MAF2C58RAF2S08AF3L05AF3L05PAF3S11AF3T02AF3T02JAF3V02AF3V02JAF3V09AF3V09AAF3W04AF3W04D
- Catalog No
- Amount recalled
- 3,444 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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