Z-2027-2009

Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external...

Name: Z-2027-2009 Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external...
Creator: Smith & Nephew Inc
Published: 2009-01-23
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2009-01-23 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint on 2009-01-23. The reason FDA records is "Hinge failure: The product is cracking or breaking during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2027-2009
Status: Terminated
Initiated: 2009-01-23
Posted: 2009-09-15
Terminated: 2013-07-29
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint.
Product code: JDW Pin, Fixation, Threaded
Reason for recall: Hinge failure: The product is cracking or breaking during use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The Smith & Nephew Sales Representatives were notified of the problem and the recall via certified letter and e-mail on 01/23/2009. A second notice was sent to the hospitals on 06/06/2009. All affected Smith & Nephew International Distributors were notified via email on 01/23/2009. They were instructed to immediately notify their accounts concerning the recall. Smith & Nephew c/o Return Goods, 4287 Delp St, Memphis, TN 38118
Quantity in commerce: 7,089 units
Distribution: Worldwide Distribution: USA, Turkey, Denmark, Germany, Malaysia, Hong Kong, Korea, Switzerland, Japan, Singapore, Canada, New Zealand, Australia, and Italy.
Product codes and lots: All Lots

Product code JDW

K994143Class IISmith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories]Smith & Nephew, Inc. / cleared 2000-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)