Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior

FDA device recall Z-2176-2012 · posted 2012-08-09 · Terminated

Recall details

Recalling firm

Stryker Spine

Reason for recall

Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument.

Action taken

Stryker sent an Urgent Product Recall letters/return response forms dated April 5, 2012, via FedEX to all affected customers. 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 location to identify the product. Reconcile any SLIDE Implant Blockers with catalog and lot numbers referenced above. Retrieve and return the affected product using the enclosed pre-paid mailing label to Stryker Spine 59 Route 17 South, Allendale, New Jersey, 07401. For questions customers were instructed to call 201-760-8298.

Root cause

Component design/selection

Status

Terminated

Product code

MDM

Quantity affected

109 Lots

Distribution

Nationwide Distribution including NC, AR, TN, MA, IL, GA, NY, LA, MN, MO, OH, KS, NM, TX, KS,and IN.

Date initiated

2011-03-21

Date posted

2012-08-09

Date terminated

2013-03-21

Location

Allendale, NJ