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U.S. Department of Health and Human Services

Class 2 Device Recall Steinmann Pin

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  Class 2 Device Recall Steinmann Pin see related information
Date Initiated by Firm August 12, 2013
Date Posted September 04, 2013
Recall Status1 Terminated 3 on February 12, 2014
Recall Number Z-2158-2013
Recall Event ID 66029
510(K)Number K863764  
Product Classification Pin, fixation, smooth - Product Code HTY
Product Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911***

Models:
1620-109 1636-509
1620-509 1640-509
1620-609 1648-509
1620-709 1648-509T
1624-109 1648-609
1624-509 1648-609T
1624-509T
1628-509
1632-509
1632-609


A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Code Information Product # Lot Number  1620-109 0213216244  1620-109 0213216804  1620-109 0313217447  1620-109 0413219296  1620-109 0413219479  1620-109 0613222208  1620-509 0213216077  1620-509 0213216598  1620-509 0213216740  1620-509 0313217912  1620-509 0313217980  1620-509 0413219446  1620-509 0413219514  1620-509 0513220340  1620-509 0613222209  1620-509 0613222677  1620-509 0613222950  1620-609 0213216021  1620-609 0213216987  1620-609 0313218036  1620-609 0413218860  1620-709 0313217801  1620-709 0413218861  1620-709 0513220659  1620-709 0613222204  1620-709 0613222465  1620-709 0613223531  1620-709 0713224375  1624-109 0213216721  1624-109 0313218583  1624-109 0413219836  1624-109 0413219934  1624-109 0613222761  1624-109 0713223840  1624-509 0213216018  1624-509 0213217203  1624-509 0313217576  1624-509 0313218461  1624-509 0413219480  1624-509T 0213215841  1628-509 0213217207  1628-509 0413219845  1628-509 0513220335  1628-509 0513220422  1628-509 0613222210  1632-509 0213216079  1632-509 0213216820  1632-509 0313218668  1632-509 0313218715  1632-509 0513220951  1632-509 0613222467  1632-509 0613223364  1632-609 0413219600  1636-509 0313218458  1636-509 0413218937  1640-509 0213216975  1640-509 0213216985  1640-509 0313217640  1640-509 0313217911  1640-509 0413219741  1640-509 0413219936  1640-509 0513220770  1648-509 0213216078  1648-509T 0213216803  1648-609 0213216295  1648-609 0513221947  1648-609T 0413220144  
Recalling Firm/
Manufacturer		 MicroAire Surgical Instruments, LLC
3590 Grand Forks Blvd
Charlottesville VA 22911-9001
For Additional Information Contact Donna Elliott
434-975-8370
Manufacturer Reason
for Recall		 A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
FDA Determined
Cause 2		 Packaging process control
Action MicroAire Surgical LLC sent an Urgent Medical Device Recall letter dated August 12, 2013, to all affected customers. The letter advised consignees recover and quarantine the affected product so that it does not make it into the surgical process. Customers were instructed to either return affected product to MicroAire for inspection or they could inspect the product for the defect by looking at the seal area on the inside sterile package (short non-chevron side). The recalling firm further advised distributors to contact all of their customers to recover and quarantine the product so that it does not make it into the surgical process. Customers with questions were instructed to call 434-975-8370. For questions regarding this recall call 434-975-8370.
Quantity in Commerce 15786 total units
Distribution Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = HTY and Original Applicant = THE MEDICAL GROUP, INC.
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