Genesis Uni Articular Inserts recallZ-0304-05 · Smith & Nephew Inc · initiated Jun 21, 2004
Terminated All recalls posted in December 2004
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
The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.
FDA root cause category: Other
What the company is doing
Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email) on 06/21/2004 to request the return of any in stock product.
Recall details
- Recall number
- Z-0304-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 21, 2004
- Posted by the FDA
- Dec 14, 2004
- Recalling firm
- Smith & Nephew Inc
- Quantity
- 11,339 units were distributed
- Product code
- HSX
- FDA submissions
- K912735
- Distribution
- Nationwide, 43 consignees, 17 countries: Germany, France, Australia, Italy, Switzerland, United Arab Emirates, Belgium, Japan, United Kingdom, Singapore, Spain, Taiwan. Sweden, Canada Venezuela, South Africa, and Israel.
Product description
Genesis Uni Articular Inserts
Code information (models, lots, serial numbers)
Genesis Uni Articular Inserts 71248108, 71248109, 71248110, 71248111, 71248112, 71248208, 71248209, 71248210, 71248211, 71248212, 71248308, 71248309, 71248310, 71248311, 71248312, 71248228, 71248229, 71248230, 71248231, 71248232, 71248235, 71248328, 71248329, 71248330, 71248331, 71248332, 71248335, 71248338, 71248339, 71248340, 71248341, 71248342, 71248345 Sold internationally: 71975865, 71975866, 71975867, 71975870, 71975871, 71975872, 71975873
Other devices under the same FDA submission
7 devices cleared under K912735 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- GENESIS 725004Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- GENESIS 726203Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GENESIS 727304Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GENESIS 71248338Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GENESIS 71243308Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GENESIS 71243609Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GENESIS 71243619Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 29816).
- Z-0305-05 · TerminatedTibial Base Plates
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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