Versys Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST… recallZ-0070-2014 · 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-0070-2014
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: 6380
Product code: LPH
FDA submissions: K953337
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

Versys 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 11X160MM; POR FULLCT LM FEM ST 11 EXT POR FULL-CT FEM ST 12X160MM VERSYS BEADED FC 12X200MM 8 ST POR FULLCT FEM ST 12 LOW EXT POR FLCT FEM ST 12.0X190 STR POR FULLCT FEM ST 12 EXT POR FULL-CT FEM ST LM 12X160MM POR FULLCT LM FEM ST 12 EXT POR FULL-CT FEM ST 13X160MM VERSYS HIP SYSTEM REVISION FEMORAL BEADED FULLCOAT PLUS COLL POR FULLCT FEM ST 13 LOW EXT POR FLCT FEM ST 13.5X190 STR POR FULLCT FEM ST 13 EXT POR FULL-CT FEM ST LM 13X160MM POR FULLCT LM FEM ST 13 EXT POR FULL-CT FEM ST 14X160MM VERSYS BEADED FC 14X200MM 8 ST POR FULLCT FEM ST 14 LOW EXT POR FULLCT FEM ST 14 EXT POR FULL-CT FEM ST LM 14X160MM POR FULLCT LM FEM ST 14 EXT POR FULL-CT FEM ST 15X160MM VERSYS BEADED FC 15X200MM 8 ST POR FULLCT FEM ST 15 LOW EXT POR FLCT FEM ST 15.0X190 STR POR FLCT FEM ST 15.0X250 STR POR FULLCT FEM ST 15 EXT POR FULL-CT FEM ST LM 15X160MM POR FULLCT FEM ST 15 XEXT POR FULLCT LM FEM ST 15 EXT POR FULL-CT FEM ST 16X160MM VERSYS BEADED FC 16X200MM 8 ST POR FULLCT FEM ST 16 LOW EXT POR FLCT FEM ST 16.5X190 STR POR FLCT FEM ST 16.5X250 STR POR FULLCT FEM ST 16 EXT POR FULL-CT FEM ST LM 16X160MM POR FULLCT FEM ST 16 XEXT POR FULLCT LM FEM ST 16 EXT POR FULL-CT FEM ST 17X160MM VERSYS BEADED FC 17X200MM 8 ST POR FULLCT FEM ST 17 EXT POR FULL-CT FEM ST LM 17X160MM POR FULLCT FEM ST 17 XEXT POR FULLCT LM FEM ST 17 EXT POR FULL-CT FEM ST 18X160MM VERSYS BEADED FC 18X200MM 8 ST POR FLCT FEM ST 18.0X190 STR POR FLCT FEM ST 18.0X250 STR POR FULLCT FEM ST 18 EXT POR FULL-CT FEM ST LM 18X160MM POR FULLCT FEM ST 18 XEXT POR FULLCT LM FEM ST 18 EXT POR FULL-CT FEM ST 19X160MM POR FLCT FEM ST 19.5X190 STR POR FLCT FEM ST 19.5X250 STR POR FULLCT FEM ST 19 EXT POR FLCT FEM STEM LM 19X160MM POR FULLCT FEM ST 19 XEXT POR FULLCT LM FEM ST 19 EXT POR FULL-CT FEM ST 20X160MM VERSYS BEADED FC 20X200MM 8 ST POR FULLCT FEM ST 20 EXT POR FLCT FEM STEM LM 20X160MM POR FULLCT FEM ST 20 XEXT POR FULLCT LM FEM ST 20 EXT POR FULL-CT FEM ST 21X160MM POR FLCT FEM ST 21.0X190 STR POR FLCT FEM ST 21.0X250 STR POR FULLCT FEM ST 21 EXT POR FLCT FEM STEM LM 21X160MM POR FULLCT FEM ST 21 XEXT POR FULLCT LM FEM ST 21 EXT POR FULLCT FEM STEM 22X160MM POR FLCT FEM ST 22.5X190 STR POR FLCT FEM ST 22.5X250 STR POR FULLCT FEM ST 22 EXT POR FLCT FEM STEM LM 22X160MM POR FULLCT FEM ST 22 XEXT POR FULLCT LM FEM ST 22 EXT. Used in total hip replacement.

Code information (models, lots, serial numbers)

Part Number Range: 00-7843-011/022-06/56

Other devices under the same FDA submission

22 devices cleared under K953337 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

VerSys® 8018-36-02
Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
24 reports
VerSys® 8018-32-02
Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented
21 reports
VerSys® 8018-32-01
Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
10 reports
VerSys® 8018-28-02
Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented
9 reports
VerSys® 8018-36-03
Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
8 reports
VerSys® 8018-36-01
Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented
6 reports
VerSys® 8018-28-01
Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
5 reports
VerSys® 8018-32-03
Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented
5 reports
VerSys® 8018-28-05
Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented
4 reports
VerSys® 8018-28-03
Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented
3 reports
VerSys® 8018-28-14
Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
3 reports
VerSys® 8018-36-04
Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
3 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 65799).

Z-0068-2014 · Terminated
Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.
Z-0069-2014 · Terminated
CPT 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-0073-2014 · Terminated
NexGen 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 · Terminated
NexGen 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 · Terminated
Natural-Knee Flex Femoral Component. Provides increased flexion capability.
Z-0076-2014 · Terminated
Zimmer Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint.
Z-0077-2014 · Terminated
Gender Solutions" Patello-Femoral Component
Z-0078-2014 · Terminated
Natural-Knee II Femoral Component
Z-0080-2014 · Terminated
NexGen 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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