Smith & Nephew Orthopaedics PIP (proximal Interphalangeal)… recallZ-2027-2009 · Smith & Nephew Inc · initiated Jan 23, 2009
Terminated All recalls posted in September 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Hinge failure: The product is cracking or breaking during use.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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
Recall details
- Recall number
- Z-2027-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 23, 2009
- Posted by the FDA
- Sep 15, 2009
- Recalling firm
- Smith & Nephew Inc
- Quantity
- 7,089 units
- Product code
- JDW
- FDA submissions
- K994143
- Distribution
- Worldwide Distribution: USA, Turkey, Denmark, Germany, Malaysia, Hong Kong, Korea, Switzerland, Japan, Singapore, Canada, New Zealand, Australia, and Italy.
Product description
Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint.
Code information (models, lots, serial numbers)
All Lots
Other devices under the same FDA submission
27 devices cleared under K994143 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SPATIAL FRAME 71070720Smith & Nephew, Inc. · PIN, FIXATION, THREADED15 reports
- SPATIAL FRAME 71070710Smith & Nephew, Inc. · PIN, FIXATION, THREADED9 reports
- SPATIAL FRAME 71070705Smith & Nephew, Inc. · PIN, FIXATION, THREADED7 reports
- SPATIAL FRAME 71070200Smith & Nephew, Inc. · PIN, FIXATION, THREADED7 reports
- SPATIAL FRAME 71070220Smith & Nephew, Inc. · PIN, FIXATION, THREADED5 reports
- ILIZAROV 102107Smith & Nephew, Inc. · PIN, FIXATION, THREADED5 reports
- Jet-X 71062250Smith & Nephew, Inc. · PIN, FIXATION, THREADED3 reports
- SPATIAL FRAME 71070310Smith & Nephew, Inc. · PIN, FIXATION, THREADED2 reports
- SPATIAL FRAME 71070125Smith & Nephew, Inc. · PIN, FIXATION, THREADED2 reports
- SPATIAL FRAME 71070730Smith & Nephew, Inc. · PIN, FIXATION, THREADED2 reports
- Jet-X 71065401Smith & Nephew, Inc. · PIN, FIXATION, THREADED2 reports
- Jet-X 71064002Smith & Nephew, Inc. · PIN, FIXATION, THREADED2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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