Date Initiated by Firm | January 11, 2016 |
Date Posted | February 22, 2016 |
Recall Status1 |
Terminated 3 on May 23, 2017 |
Recall Number | Z-0836-2016 |
Recall Event ID |
73142 |
510(K)Number | K033363 |
Product Classification |
Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
|
Product | ZIMMER UNI HIGH FLEX PRECOAT FEM
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
various sizes
These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees." |
Code Information |
Item numbers: 00-5842-011-01 00-5842-011-02 00-5842-012-01 00-5842-012-02 00-5842-013-01 00-5842-013-02 00-5842-014-01 00-5842-014-02 00-5842-015-01 00-5842-015-02 00-5842-016-01 00-5842-016-02 00-5842-017-01 00-5842-017-02 Lot numbers: 11002504 11002764 11002766 11002767 11002780 11002782 11002784 11003009 11003028 11003042 11003048 11003345 11003366 11003367 11003370 11003371 11003384 11003398 11003399 11003413 11003414 11003433 11003452 11003488 11003490 11003491 11003584 11003587 11003588 11003589 11003603 11003611 11003635 11003642 11003649 11003658 11003659 11003660 11003661 11003689 11003855 11003868 11003878 11003904 11003921 11003944 11003959 11003960 11003974 11004052 11004056 11004074 11004146 11004150 11004152 11004161 11004204 11004306 11004335 11004401 11004402 11004408 11004446 11004450 11004451 11004452 11004455 11004463 11004553 11004563 11004564 11004626 11004677 11004707 11004715 11004720 11004726 11004754 11004790 11004798 11004825 11004830 11004833 11004834 11004851 11004852 11004911 11004912 11004918 11004930 11004986 11004987 11004988 11004993 11005001 11005003 11005031 11005032 11005087 11005090 11005093 11005120 11005121 11005126 11005168 11005194 11005203 11005204 11005214 11005239 11005240 11005242 11005244 11005251 11005349 11005350 11005357 11005414 11005583 11005607 11005608 11005610 11005646 11005749 11005750 11005781 11005800 11005804 11005932 11005938 11005984 11005995 11006023 11006025 11006048 11006060 11006068 11006075 11006145 11006153 11006161 11006162 11006169 11006172 11006200 11006215 11006222 11006223 11006253 11006255 11006271 11006311 11006411 11006439 11006480 11006539 11006550 11006596 11006625 11006715 11006739 11006743 11006751 11006761 11006836 11006884 11006885 11006991 11007049 11007051 11007090 11007212 11007276 11007277 11007311 11007334 11007337 11007439 11007565 11007567 11007584 11007585 11007672 11007854 11007962 11008266 11008315 61774103 61777605 61777607 61777608 61777609 61777610 61777614 61777618 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62231323 62231324 62234369 62234370 62234371 62234372 62234373 62234374 62238194 62238195 62238196 62238197 62238198 62238199 62238200 62238201 62238202 62238203 62238204 62238205 62238206 62238207 62238208 62238216 62245903 62245904 62245905 62245906 62245907 62245908 62245909 62245911 62245912 62245913 62245914 62245925 62245926 62252307 62252312 77001374 77001375 77001376 77001377 77001378 77001379 77001380 77001381 77001382 77001383 77001384 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 1800 W Center St Warsaw IN 46580-2304
|
For Additional Information Contact | Consumer Relations Call Center 800-447-5633 |
Manufacturer Reason for Recall | LDPE bag containing the implant adheres to the highly polished implant surface. |
FDA Determined Cause 2 | Process control |
Action | Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.
For questions regarding this recall call 800-447-5633. |
Quantity in Commerce | 32537 |
Distribution | Worldwide Distribution - US (nationwide) and Internationally to
ARGENTINA
AUSTRALIA
AUSTRIA
BARBADOS
BELGIUM
BERMUDA
BOLIVIA
BRAZIL
CARIBBEAN
CHILE
CHINA
COLOMBIA
COST RICA
DENMARK
DOMINICAN REPUBLIC
DORAL FL
ECUADOR
EL SALVADOR
ENGLAND
FRANCE
GERMANY
GUATEMALA
HONDURAS
HONG KONG
INDIA
ISRAEL
ITALY
JAMAICA
JAPAN
KOREA
MALAYSIA
MEXICO
NEW ZEALAND
NICARAGUA
PANAMA
PERU
SINGAPORE
SPAIN
SWEDEN
SWITZERLAND
TAIWAN
THAILAND
VENEZUELA
WEST INDIES
Canary Islands
Croatia
Cyprus
Czech Republic
Canada |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HSX
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