| Date Initiated by Firm | October 25, 2010 |
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| Date Posted | March 18, 2011 |
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| Recall Status1 |
Terminated 3 on March 20, 2012 |
| Recall Number | Z-1727-2011 |
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| Recall Event ID |
56962 |
| HDE Number | H020008 |
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| Product Classification |
Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde - Product Code OJZ
|
| Product | Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein)
"Catalog numbers: 300-50, 300-55
OP-1 Putty is authorized by Federal law for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes. |
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| Code Information |
OP-1 Putty, Catalog #300-50 Lot Number Expiry Date FC0902004 8/31/2009 FC0902005 8/31/2009 FC0903002 8/31/2009 FC0903004 8 /31/2009 FC0903005 8/31/2009 FC0905003 3/31/2010 FC0905005 3/31/2010 FC0906002 4/30/2010 FC0907002 4/30/2010 FC0907005 4/30/2010 FC0908001 4/30/2010 FC0908003 2/28/2010 FC0908004 4/30/2010 FC0908006 4/30/2010 FC0909005 4/30/2010 OP-1 Putty, catalog #300-55 Lot Number Expiry Date FC0909002 8/31/2010 FC0909003 8/31/2010 FC0909004 8/31/2010 FC0909008 8/31/2010 FC0909009 8/31/2010 FC0909012 8/31/2010 FC0909013 8/31/2010 FC0910003 8/31/2010 FC0910004 8/31/2010 FC0911001 8/31/2010 FC0911002 8/31/2010 FC0912002 8/31/2010 FC0912004 8/31/2010 FC1001002 8/31/2010 FC1002001 8/31/2010 FC1002004 8/31/2010 FC1002005 8/31/2010 FC1003001 10/31/2010 FC1003003 10/31/2010 FC1004001 10/31/2010 FC1005001 10/31/2010 FC1005002 10/31/2010 FC1005003 10/31/2010 FC1006001 10/31/2010 FC1007001 1/31/2012 FC1007004 1/31/2012 FC1007005 1/31/2012 FC1007006 1/31/2012 FC1007007 1/31/2012 FC1008001 1/31/2012 FC1008002 1/31/2012 FC1009002 1/31/2012 FC1009004 1/31/2012 FC1009005 1/31/2012 |
Recalling Firm/
Manufacturer |
Stryker Biotech
35 South St
Hopkinton MA 01748-2218
|
| For Additional Information Contact | SAME
508-478-5200 |
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Manufacturer 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 |
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FDA Determined
Cause 2 | Labeling Change Control |
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| Action | 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. |
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| Quantity in Commerce | 2861 units |
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| Distribution | Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| HDE Database | HDEs with Product Code = OJZ
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