Recall Z-1247-2011 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Spine
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
| Date | Feb 15, 2011 (initiated Jan 7, 2011) |
| Status | Terminated |
| Reason | 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 | 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 Cu |
| Quantity | 25 units |
| Distribution | Nationwide Distribution including MA, MN, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.