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

FDA device recall Z-1247-2011 · posted 2011-02-15 · Terminated

Recall details

Recalling firm

Stryker Spine

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LXH

Quantity affected

25 units

Distribution

Nationwide Distribution including MA, MN, and PA.

Date initiated

2011-01-07

Date posted

2011-02-15

Date terminated

2015-03-08

Location

Allendale, NJ