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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Event Detail

Event ID 62365
Product Type Devices
Status Ongoing
Recalling Firm Stryker Howmedica Osteonics Corp.
City Mahwah
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-12-22
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches (3760-0305/-0709/-1113 and 3761-0305/-0709/-1113) and Tibial Templates (3750-0003/-0005/-0007/-0009/-0013) to prepare the tibia for baseplate implantation. Per the surgical protocol for Duracon and Scorpio Total Knee Systems with Xcelerate Instrumentation (LSPK31 03/03), tibial templates are used to determine the appropriate coverage of the tibial plateau. Once a template size is selected, the device is secured to the plateau with fixation pins, and the tibial punch tower is assembled by placing the tower onto the two small locating pins on the tibial template. A keel punch is then selected, assembled into the channel of the tower, and impacted with a mallet. Depending on the intended implant size, several keel punches of increasing size may be utilized to incrementally enlarge the cavity. Each keel punch is advanced until it fully seats on the tibial template. Tibial preparation is considered complete when the final keel punch fully seats on the tibial template. Catalog Number 8000-1089. Lot Number(s): RD6E087, RD6E187; RD6E083; RD6E082; RD6C178; RD5W268; RD5W267; RD5V260; RD5W320; RD5V240; RD5V239; RD5V238; RD5N407; RD5S104; RD5S103; RD5T177; RD5T179; RD5S259; RD5T178; RD5N406; RD5S300; RD5T298; RD5W381; RD6E086; RD6E089; RD6E090; RD6E091; RD6E158; RD6E159; RD6E160; RD6E186. Class II Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower. The slot that guides the stem of the keel punch into the channel of the tower was later determined to be undersized. 152 units Z-2084-2012
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