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U.S. Department of Health and Human Services

Class 2 Device Recall Birmingham Hip Resurfacing Femoral Head

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  Class 2 Device Recall Birmingham Hip Resurfacing Femoral Head see related information
Date Initiated by Firm May 11, 2018
Date Posted May 21, 2018
Recall Status1 Terminated 3 on April 05, 2019
Recall Number Z-2268-2018
Recall Event ID 80126
PMA Number P040033 
Product Classification Prosthesis, hip, semi-constrained, metal/metal, resurfacing - Product Code NXT
Product Birmingham Hip Resurfacing Acetabular Cup with Impactor:
(a) Size 56 mm, REF 74120156
(b) Size 64 mm, REF 74120164
(c) Size 54 mm, REF 74122154
(d) Size 58 mm, REF 74122158
(e) Size 60 mm, REF 74122160
(f) Size 62 mm, REF 74122162
Code Information (a) Size 56 mm, REF 74120156, Lot 16CW01824 (b) Size 64 mm, REF 74120164, Lot 16DW10975 (c) Size 54 mm, REF 74122154, Lot 16BW17747 (d) Size 58 mm, REF 74122158, Lot 16CW16199 (e) Size 60 mm, REF 74122160, Lot 08GW18001B (f) Size 62 mm, REF 74122162, Lot 16CW20851
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
978-749-1440
Manufacturer Reason
for Recall		 The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by email and letter on 05/11/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew.
Quantity in Commerce 6 units
Distribution OH, TX, CO, TN, MI, PA, NJ
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.
PMA Database PMAs with Product Code = NXT and Original Applicant = Smith & Nephew, Inc.
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