Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tiss

FDA device recall Z-2136-2014 · posted 2014-08-01 · Terminated

Recall details

Recalling firm

X Spine Systems Inc

Reason for recall

Revision B of the tissue shields of the device was 7 mm longer than the previous design.

Action taken

X-Spine systems contacted both customers via telephone and instructed to return the affected product back to X-Spine. All product has been recovered. The distributors have already returned the recalled product. No product was utilized in any surgical procedure. Immediate Action Taken: X-spine inventory was reviewed and two pieces of each size were recovered from finished inventory. The X-spine sales person returned the product. The distributor has returned the remaining product. The devices were recovered prior to use in any surgical procedure. For further questions please call (937) 847-8410

Root cause

Employee error

Status

Terminated

Product code

FZX

Quantity affected

A total of 5-pieces of each part number distributed

Distribution

US Distribution including the states of FL and MO.

Date initiated

2014-07-11

Date posted

2014-08-01

Date terminated

2014-08-14

Location

Miamisburg, OH