Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401

FDA device recall Z-2084-2012 · posted 2012-07-26 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower. The slot that guides the stem of the keel punch into the channel of the tower was later determined to be undersized.

Action taken

Stryker Orthopaedics sent an Urgent Product Recall/Recall Acknowledgement letter dated January 10, 2012, to all affected customers. The letter identified the product(s) the problem and the action needed to be taken by the customer. Customers were instructed to contact their Stryker Sales Representative to arrange for return of the affected product. Customers were asked to fax back the attached Product Recall Acknowledgement Form as soon as possible to 201-831-6069. For questions customers should call 201-972-2100. For questions regarding this recall call 201-831-5970.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LXH

Quantity affected

152 units

Distribution

Worldwide Distribution

Date initiated

2011-12-22

Date posted

2012-07-26

Date terminated

2013-06-13

Location

Mahwah, NJ