Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein) "Catalog numbers: 300-50, 300-55 OP-1 Putty is auth

FDA device recall Z-1727-2011 · posted 2011-03-18 · Terminated

Recall details

Recalling firm

Stryker Biotech

Reason for recall

A change to the Preparation for Use section was identified where 2.5cc was replaced with 2cc-3cc volume and was not approved

Action taken

The firm, Stryker Biotech, sent a "Medical Device Correction" letter on October 15, 2010 via return receipt letter to all customers. The letter contains labeling with the approved Preparation for Use Section of 2.5 cc volume and included the revised copy of the Package Insert. Additionally, the letter described the product, problem and actions to be taken. The customers were instructed to follow the new instructions provided and to keep the new instructions in mind when using the OP-1 Putty. If you have any questions concerning this communication, please contact 508-416-5326 or Stryker Biotech's Pharmacovigilance department at PVG@stryker.com.

Root cause

Labeling Change Control

Status

Terminated

Product code

OJZ

Quantity affected

2861 units

Distribution

Nationwide distribution.

Date initiated

2010-10-25

Date posted

2011-03-18

Date terminated

2012-03-20

Location

Hopkinton, MA