Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ

FDA device recall Z-0895-2011 · posted 2011-01-12 · Terminated

Recall details

Recalling firm

Stryker Spine

Reason for recall

Stryker Spine has received reports of the Disc Space Distractors failing during surgical procedures.

Action taken

Stryker Spine sent an URGENT PRODUCT RECALL letter dated December 7, 2010, via Fedex to all affected customers.. The letter identified the product, the problem, and the action they should take. Customers were instructed to examine their inventory and hospital locations to identify the product. Reconcile IBD Disc Space Distractors with the catalog and lot numbers referenced. Complete the Customer Response Form and distribution sheet and fax a copy of the Customer Response Form to Regulatory Compliance at 201-760-8370. 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 regarding this recall call 201-760-8206.

Root cause

Other

Status

Terminated

Product code

LXH

Quantity affected

21 units

Distribution

Nationwide Distribution including AZ, FL, MA, NY, PA, and TX

Date initiated

2010-12-07

Date posted

2011-01-12

Date terminated

2012-11-14

Location

Allendale, NJ