FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint.
- Recall number
- Z-2027-2009
- Recalling firm
- Smith & Nephew Inc
- Product
- Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint.
- Status
- Terminated
- Initiated
- 2009-01-23
- Posted
- 2009-09-15
- Terminated
- 2013-07-29
- Reason
- Hinge failure: The product is cracking or breaking during use.
- 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
- 7,089 units
- Distribution
- Worldwide Distribution: USA, Turkey, Denmark, Germany, Malaysia, Hong Kong, Korea, Switzerland, Japan, Singapore, Canada, New Zealand, Australia, and Italy.
- Lot, serial or model codes
- All Lots
- 510(k) numbers
- ["K994143"]
- PMA numbers
- not on file
- Product code
- JDW
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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