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U.S. Department of Health and Human Services

Class 2 Device Recall Howmedica Osteonics Corp.

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 Class 2 Recall
Howmedica Osteonics Corp.
see related information
Date Posted July 26, 2012
Recall Status1 Terminated on June 13, 2013
Recall Number Z-2084-2012
Recall Event ID 62365
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Stryker Orthopaedics sent an Urgent Product Recall/Recall Acknowledgement letter dated January 10, 2012, to all affected customers. The letter identified the product(s) the problem and the action needed to be taken by the customer. Customers were instructed to contact their Stryker Sales Representative to arrange for return of the affected product. Customers were asked to fax back the attached Product Recall Acknowledgement Form as soon as possible to 201-831-6069. For questions customers should call 201-972-2100. For questions regarding this recall call 201-831-5970.
Quantity in Commerce 152 units
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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