| Class 2 Device Recall TRIGEN INTERTAN NAIL |  |
Date Initiated by Firm | April 04, 2014 |
Date Posted | May 20, 2014 |
Recall Status1 |
Terminated 3 on July 01, 2017 |
Recall Number | Z-1636-2014 |
Recall Event ID |
68043 |
510(K)Number | K040212 |
Product Classification |
Nail, fixation, bone - Product Code JDS
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Product | TRIGEN INTERTAN NAIL:
(1) REF 71675201, 10 MM X 18 CM, 125 degree,
(2) REF 71675202, 11.5 MM X 18 CM, 125 degree,
(3) REF 71675203, 13 MM X 18 CM, 125 degree,
(4) REF 71675204, 10 MM X 20 CM, 125 degree,
(5) REF 71675205, 11.5 MM X 20 CM, 125 degree,
(6) REF 71675207, 10 MM X 18 CM, 130 degree,
(7) REF 71675208, 11.5 MM X 18 CM, 130 degree,
(8) REF 71675211, 11.5 MM X 20 CM, 130 degree,
Smith & Nephew, Inc. Orthopedic fixation device. |
Code Information |
TRIGEN INTERTAN NAIL: (1) REF 71675201, Lot Numbers: 13LT36305, 13LT36306, 13LT36547, 13LT36548, 13LT37009, 13LT37010, 13MT37347, 13MT37665, 13MT37667, 13MT37668, 14AT38179, 14AT38180, 14AT38181, 14T38182, 14AT38183, 14AT38189, 14AT38190 (2) REF 71675202, Lot Numbers: 13LT36308, 13LT36549, 13LT37011, 13MT37348, 14AT38750 (3) REF 71675203, Lot Numbers: 13KT36106, 13LT36596, 14AT38494 (4) REF 71675204, Lot Numbers: 13LT36597, 13LT37012, 14AT38495, 14AT38660 (5) REF 71675205, Lot Number 13LT36598 (6) REF 71675207, Lot Numbers: 13LT363089, 13LT36310, 13LT36599, 13LT37058, 13LT37059, 13LT37063, 13MT37264, 13MT37265, 13MT37266, 13MT37329, 13MT37349, 13MT37350, 13MT37669, 13MT37671, 13MT37672 (7) REF 71675208, Lot Numbers: 13LT36311, 13LT36312, 13LT36600, 13LT37060, 13LT37061, 13MT37351, 13MT37666, 13MT37963 (8) REF 71675211, Lot Number 13LT36313 |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 1450 E. Brooks Rd Memphis TN 38116
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For Additional Information Contact | Joe Metzger 978-749-1330 |
Manufacturer Reason for Recall | A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
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FDA Determined Cause 2 | Process control |
Action | The firm initiated the recall via an "Urgent - Product Recall 1st Notification - Urgent" letter and e-mail on 04/04/2014, identifying the product, explaining the problem, and the potential risk associated with using the product. Customers are to inspect their inventory, and locate and quarantine any affected product. Additionally, the Inventory Return Certification form should be completed and returned along with any affected product identified, once a Return Authorization number has been obtained from Smith & Nephew's Safety Affairs Department. |
Quantity in Commerce | 1,253 units total |
Distribution | Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela. |
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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510(K) Database | 510(K)s with Product Code = JDS
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