Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the specified disc space; the t-handle can then be rotated clockwise expanding the distal paddle assembly to a specified height. Once the determined height has been achieved the t-handle can be rotated counter-clockwise retracting the paddles and then removed from the defect site. instrument is not used to sustain or support life. it is intended to be used as a manual surgical instrument during inter body disk replacement to distract the vertebrae to aid in removal of disc space, cartilage, bone and soft tissue.
FDA Recall Z-0895-2011 · Posted 2011-01-12
Advertisement
Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-12-07
Date Terminated2012-11-14
Product Quantity21 units
Reason for Recall
Stryker Spine has received reports of the Disc Space Distractors failing during surgical procedures.
Firm Action
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
Distribution Pattern
Nationwide Distribution including AZ, FL, MA, NY, PA, and TX
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement