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U.S. Department of Health and Human Services

Class 2 Device Recall Mantis Tap Sleeve

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 Class 2 Device Recall Mantis Tap Sleevesee related information
Date Initiated by FirmJanuary 07, 2011
Date PostedFebruary 15, 2011
Recall Status1 Terminated 3 on March 08, 2015
Recall NumberZ-1247-2011
Recall Event ID 57665
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductMantis 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.
Code Information All lots - 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. All lots
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information ContactTiffani Rogers
201-760-8206
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Other
ActionStryker 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.
Quantity in Commerce25 units
DistributionNationwide Distribution including MA, MN, and PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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