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Zimmer Manufacturing B.V.

Country not established FDA establishment FEI 1000132037

Devices
0
Registrations
FDA
FDA recalls
91

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
1000132037
Address
ROUTE 1, KM. 123.4, BLDG. 2, MERCEDITA, PR, 00715

FDA recalls91

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Showing the 10 most recent of 91 recalls.

  • 2016

    • 4 May 2016 Z-1673-2016 Class II Terminated A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador,…
      Full distribution text Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
      Submission number: K060710
    • 4 May 2016 Z-1674-2016 Class II Terminated A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador,…
      Full distribution text Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
      Submission number: K063303
    • 4 May 2016 Z-1675-2016 Class II Terminated A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador,…
      Full distribution text Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
      Submission number: K082527
    • 4 May 2016 Z-1676-2016 Class II Terminated A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador,…
      Full distribution text Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
      Submission number: K111447
    • 4 May 2016 Z-1677-2016 Class II Terminated A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador,…
      Full distribution text Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
      Submission number: K112885
    • 4 May 2016 Z-1678-2016 Class II Terminated A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador,…
      Full distribution text Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
      Submission number: K142281
    • 4 May 2016 Z-1679-2016 Class II Terminated A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador,…
      Full distribution text Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
      Submission number: K142442
    • 4 May 2016 Z-1680-2016 Class II Terminated A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador,…
      Full distribution text Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
      Submission number: K143165
    • 4 May 2016 Z-1681-2016 Class II Terminated A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador,…
      Full distribution text Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
      Submission number: K143321
    • 4 May 2016 Z-1682-2016 Class II Terminated A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador,…
      Full distribution text Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
      Submission number: K150818
Show the 25 most recent of 91 recalls

  • 2016

    • 4 May 2016 Z-1683-2016 Class II Terminated A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador,…
      Full distribution text Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
      Submission number: K840643
    • 4 May 2016 Z-1684-2016 Class II Terminated A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador,…
      Full distribution text Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
      Submission number: K934765
    • 17 Mar 2016 Z-1340-2016 Class II Terminated The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580. Distribution: Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries…
      Full distribution text Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).
      Submission number: K113369
    • 17 Mar 2016 Z-1341-2016 Class II Terminated The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580. Distribution: Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries…
      Full distribution text Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).
      Submission number: K113369
    • 11 Jan 2016 Z-1099-2016 Class II Terminated As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. Distribution: US Nationwide Distribution
    • 11 Jan 2016 Z-1100-2016 Class II Terminated As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. Distribution: US Nationwide Distribution
    • 11 Jan 2016 Z-1101-2016 Class II Terminated As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. Distribution: US Nationwide Distribution Submission number: K955473
    • 11 Jan 2016 Z-1102-2016 Class II Terminated As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. Distribution: US Nationwide Distribution Submission number: K112885
    • 11 Jan 2016 Z-1103-2016 Class II Terminated As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. Distribution: US Nationwide Distribution Submission number: K063303
    • 11 Jan 2016 Z-1104-2016 Class II Terminated As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. Distribution: US Nationwide Distribution Submission number: K082527
    • 11 Jan 2016 Z-1105-2016 Class II Terminated As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. Distribution: US Nationwide Distribution Submission number: K111447
    • 11 Jan 2016 Z-1106-2016 Class II Terminated As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. Distribution: US Nationwide Distribution Submission number: K060710
    • 11 Jan 2016 Z-1107-2016 Class II Terminated As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. Distribution: US Nationwide Distribution
    • 11 Jan 2016 Z-1108-2016 Class II Terminated As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. Distribution: US Nationwide Distribution Submission number: K112885
    • 11 Jan 2016 Z-1109-2016 Class II Terminated As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. Distribution: US Nationwide Distribution Submission number: K960278

This is an FDA establishment record without devices in deviCERTS.