Smith & Nephew Inc: 4.5 MM X 40 MM X 150 MM HA COATED HALF PIN SST, REF 71070826, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.

Recall number

Z-1728-2012

Recalling firm

Smith & Nephew Inc

Product

4.5 MM X 40 MM X 150 MM HA COATED HALF PIN SST, REF 71070826, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.

Status

Terminated

Initiated

2012-04-13

Posted

2012-06-06

Terminated

2015-09-22

Reason

Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.

Root cause

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

1236 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

Lot, serial or model codes

Lot Numbers: 03JM10950C, 03JM10951B, 04GT81708A, 04GT82059A, 04MT85470A, 06HT00329A, 08BT17534A, 08GT21566A, 08GT21566B, 08JT23729A, 09GT34300,  09LT37634, 10CT40114, 10DT41656, 10FT43816, 10JT46330, 10KT00286, 11ET06849, 11HT09586, 11JT10409, 11KT11410

510(k) numbers

["K023921"]

PMA numbers

not on file

Product code

JDW

Firm FEI

1020279

Firm city

Memphis

Firm state

TN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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