Zimmer Unicompartmental Knee Femoral Component recallZ-0076-2014 · Zimmer, Inc. · initiated Aug 30, 2013
Class II Terminated All recalls posted in October 2013
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 Zimmer, 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 low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
FDA root cause category: Package design/selection
What the company is doing
August 30, 2013 Urgent Recall Notices were sent to Distributors, hospital risk managers and surgeons identifying the issue and directing consignees to make all affected personnel aware of the contents of the notification. The notice identified the products involved, the issue, possible adverse events associated with the issue and recommended that implants found with LDPE bag adhesion not use the product and return it to Zimmer sales representatives. Questions or concerns should be addressed to Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST.
Recall details
- Recall number
- Z-0076-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 30, 2013
- Posted by the FDA
- Oct 25, 2013
- Recalling firm
- Zimmer, Inc.
- Quantity
- 32537
- Product code
- HSX
- FDA submissions
- K033363
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
Product description
Zimmer Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint.
Code information (models, lots, serial numbers)
Part Number Range:00-5842-011/017-01/02
Other devices under the same FDA submission
37 devices cleared under K033363 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 5842-15-02Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- NA 5842-15-01Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- ZUK 00584202408Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- ZUK 00584202409Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- NA 5842-03-02Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- NA 5842-24-08Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- ZUK 00584200301Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- ZUK 00584202308Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- ZUK 00584202508Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- ZUK 00584202509Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- ZUK 00584202608Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- NA 5842-02-01Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 65799).
- Z-0068-2014 · TerminatedMultipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.
- Z-0069-2014 · TerminatedCPT Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT…
- Z-0070-2014 · TerminatedVersys Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160…
- Z-0073-2014 · TerminatedNexGen Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX…
- Z-0074-2014 · TerminatedNexGen Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF …
- Z-0075-2014 · TerminatedNatural-Knee Flex Femoral Component. Provides increased flexion capability.
- Z-0077-2014 · TerminatedGender Solutions" Patello-Femoral Component
- Z-0078-2014 · TerminatedNatural-Knee II Femoral Component
- Z-0080-2014 · TerminatedNexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
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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