| Class 2 Device Recall 2.0 MM DRILL BIT | |
Date Initiated by Firm | April 13, 2012 |
Date Posted | June 06, 2012 |
Recall Status1 |
Terminated 3 on September 22, 2015 |
Recall Number | Z-1715-2012 |
Recall Event ID |
61767 |
Product Classification |
Bit, drill - Product Code HTW
|
Product | 2.0 MM DRILL BIT, REF 71173501, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. |
Code Information |
Lot Numbers: 07BHU0004E, 07CHU0010E, 07DHU0025D, 07DHU0025E, 07LHU0004J, 07LHU0004K, 07LHU0004L, 07LHU0004M ,08AHU0004J, 08BHU0019G, 08BM20807A, 08CHU0016G, 08CHU0018F, 08FM15736B, 08JHU0008B, 08LHU0020G, 08MHU0026C, 09BHU0031E, 09BHU0031F, 09BHU0031G, 09CHU0044D, 09DHU0019, 09DHU0019B, 09DHU0036, 09DHU0036C, 09DHU0036D, 09DHU0036E, 09DHU0036F, 09EHU0003, 09EHU0003A, 09EHU0003B, 09EHU0003C, 09EHU0003D, 09EHU0003E, 09EHU0003F, 09EHU0007, 09EHU0007A, 09EHU0007B, 09EHU0007C, 09EHU0007D, 09EHU0013, 09EHU0013A, 09EHU0013B, 09EHU0013C, 09EHU0013D, 09EHU0013E, 09EHU0013F, 09FHU0005, 09FHU0005A, 09FHU0033, 09FHU0033B, 09FHU0033C, 09FHU0033D, 09FHU0033F, 09FHU0033G, 09FHU0033H, 09GM06174A, 09GM14035, 09HHU0008, 09HHU0010, 09HHU0010A, 09HHU0010B, 09HHU0010C, 09HHU0010D, 09HHU0010E, 09HHU0010F, 09HM12199, 09HM12202, 09HM17431, 09KHU0001, 09KHU0001A, 09KHU0001B, 09KHU0001C, 09KHU0001D, 09KHU0001E, 09KHU0001G, 09KHU0001H, 09KHU0001P, 09KHU0010, 09KHU0010A, 09KHU0010B, 09LM10792, 09MM01112A, 10AM02971, 10BHU0007, 10BHU0007A, 10BHU0007B, 10BHU0007C, 10BHU0007D, 10BHU0007F, 10BHU0007G, 10BHU0010, 10BHU0010A, 10BHU0010M, 10BHU0018, 10BHU0018A, 0BHU0018B, 10BHU0018C, 10BHU0018D, 10BHU0018E, 10BHU0018F, 10EHU0013, 10EHU0013A, 10EHU0013B, 10FM16220, 11CHU0015A, 11CHU0015B, 11CHU0015C, 11DHU0003, 11DHU0003A, 11DHU0005, 11DHU0005A, 11DHU0005B, 11HHU0027, 11HHU0030, 11HHU0031, 11HHU0031B, 11HHU0032, 11HHU0034, 11JHU0006, 11JHU0007, 11JHU0008, 11JHU0009, 11JHU0010, 11JHU0024, 11JHU0024A, 11KHU0007, 11KHU0016, 11LHU0004, 11LHU0005, 11LHU0005A, 11LHU0007, 11LHU0008, 11LHU0011, 11LHU0011A, 11LHU0012, 11LHU0027, 11LHU0027A, 11LHU0027C, 11LHU0027X, 11LHU0034, 11LHU0035, 11MHU0005, 11MHU0005A, 11MHU0005D, 1MHU0017, 11MM11935, 11MNG0008, 11MNG0008A, 11MNG0008B, 11MNG0009, 11MNG0009A, 11MNG0009C, 11MNG0018, 11MNG0018D, 11MNG0018E, 11MNG0025, 11MNG0025N, 11MNG0025P, 12AHU0001, 12AHU0001B, 12AHU0001C, 12AHU0014, 12BHU0010, 12BHU0010B, 12BHU0011, 12BHU0011A, 12BHU0025, 12BHU0025A, 12BHU0025B, 12BHU0025E, 12BHU0025G, 477420-14A |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 1450 E. Brooks Rd Memphis TN 38116
|
For Additional Information Contact | Joe Metzger 978-749-1330 |
Manufacturer Reason for Recall | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
FDA Determined Cause 2 | Packaging |
Action | Smith & Nephew Sales Representatives and Smith & Nephew International Distributors were notified of the problem with the affected product and the recall via email on April 13, 2012. All affected direct consignees were notified via Fed Ex on April 13, 2012. The Urgent Medical Device Recall letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the product and quarantine them immediately for return. Customers were instructed to complete the Inventory Return Certification Form included with the letter. Customers should fax or email the form to 901-566-7975 or fieldactions@smith-nephew.com. The affected product should be returned to:
Smith & Nephew
Attn: Global Field Actions
Safety Affairs
1450 Brooks Road
Memphis, Tennessee 38116
If the affected product was distributed further customers were instructed to provide a copy of the recall letter to these customers. |
Quantity in Commerce | 11987 units |
Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey |
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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