Z-1247-2011

Mantis Tap Sleeve,Mfg by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401-1677. packaged in the following...

Name: Z-1247-2011 Mantis Tap Sleeve,Mfg by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401-1677. packaged in the following...
Creator: Stryker Spine
Published: 2011-01-07
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2011-01-07 / Terminated / root cause: sterility

FDA source

Stryker Spine began a recall of Mantis Tap Sleeve,Mfg by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401-1677. packaged in the following products: Specialty Mantis Modular Tap Set -... on 2011-01-07. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1247-2011
Status: Terminated
Initiated: 2011-01-07
Posted: 2011-02-15
Terminated: 2015-03-08
Recalling firm: Howmedica Osteonics Corp
Product: 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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: sterility
FDA root cause: Other
Action: 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.
Quantity in commerce: 25 units
Distribution: Nationwide Distribution including MA, MN, and PA.
Product codes and lots: 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

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)