Mantis Tap Sleeve,Mfg by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401-1677. packaged in the following products: Specialty Mantis Modular Tap Set - Catalog #IS2162MAN; Custom Tap Sleeve - Catalog #IS830MAN; Custom Tap Sleeve, Mantis - Catalog #IS2271MAN; and Custom Mantis Modular Tap Set - Catalog #IS2080MAN The Mantis Tap Sleeves with Markers was designed to be used in a manner identical to the predicate Standard Mantis Tap Sleeve 48281315. It is to be used in conjunction with Standard Mantis Cannulated Modular Taps: 1) to protect soft tissue from the cutting edge of the tap 2) to indicate the depth at which the Tap has been inserted.

Stryker Spine has received reports that after sterilization but prior to surgery, cracks were noticed at the tantalum marker / PEI tube interface. This can likely be attributed to differences in the rate of thermal expansion between the markers and the sleeve during the sterilization cycle.

Stryker Spine sent an Urgent Product Recall letter dated January 07, 2011, to Stryker Spine sales branches and agencies where affected product was distributed. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and hospital locations to identify the product. Reconcile any Mantis Tap Sleeves with the catalog and lot numbers referenced in the letter. Complete the Customer Response Form with distribution sheet provided to assist with product reconcilation. Customers were asked to fax a copy of the Customer Response Form to Regulatory Compliance at 201-760-8370. Customers were to retrieve and return the affected product using the enclosed pre-paid mailing label to Regulatory Compliance, Stryker Spine 6 Pearl Court, Allendale, New Jersey 07401. For questions call 201-760-8180.