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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Number Range: 00-7843-011/022-06/56
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer, Inc.
- Reason for Recall:
- The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Part Number Range: 00-7843-011/022-06/56
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0070-2014
Related Recalls
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.