| Date Initiated by Firm |
January 11, 2016 |
| Date Posted |
March 12, 2016 |
| Recall Status1 |
Terminated 3 on April 13, 2017 |
| Recall Number |
Z-1121-2016 |
| Recall Event ID |
72900 |
| Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
|
| Product |
Product 23 consists of all product code: JDI and same usage:
Item no:
801100220 CPT 2 HIP STEM, X-OFFSET
801100320 CPT 3 HIP STEM, X-OFFSET
801100420 CPT 4 HIP STEM, X-OFFSET
801100005 CPT HIP STEM PETITE
801100700 CPT HIP STEM SZ 2 LONG
801100800 CPT HIP STEM SZ 3 LONG
801100222 CPT MOD HD ST/ST 22MED SH
801100322 CPT MOD HD ST/ST 22MMD LN
801100122 CPT MOD HD ST/ST 22MMD SH
801100126 CPT MOD HD ST/ST 26MMD SH
801100328 CPT MOD HD ST/ST 28MMD LN
801100228 CPT MOD HD ST/ST 28MMD ME
801100128 CPT MOD HD ST/ST 28MMD SH
801100332 CPT MOD HD ST/ST 32MMD LN
801100232 CPT MOD HD ST/ST 32MMD ME
801100132 CPT MOD HD ST/ST 32MMD SH
801100100 CPT MODULAR STEM SIZE 1 S
801100200 CPT MODULAR STEM SIZE 2 S
801100300 CPT MODULAR STEM SIZE 3 S
801100400 CPT MODULAR STEM SIZE 4 S
801100500 CPT MODULAR STEM SIZE 5 S
For use in total or hemi hip arthroplasty |
| Code Information |
lot no.: 61882616 62030937 62087634 62154310 62264269 62312479 62264269N 62033232 62097081 62264270 62303492 62097082 62264271 62324103 62264271N 61833317 61936207 61942441 61955618 61964737 62024630 62024632 62028824 62028826 62028827 62028828 62041514 62041515 62041516 62042594 62042595 62043475 62094958 62094959 62103574 62103575 62105196 62105197 62106789 62118981 62121273 62121274 62122111 62148550 62148551 62240713 62249029 62255999 62284453 62094958N 62094959N 62103574N 62105196N 62105197N 62118981N 62121273N 62121274N 62122111N 62148550N 62148551N 62249029N 62255999N 62284453N 62065267 62097089 62161471 62303493 62332024 62332024N 61907672 62069520 62161473 62227021 62161473N 62227021N 61653623 61951328 62054833 62089761 62327042 62332620 62362980 62399487 62089761N 62089763 62404691 62089763N 62075382 62086078 62377682 62399485 62075382N 62086078N 62396944 60728070N 62396944V 61593599 61593603 61636319 61636320 61636321 61636323 62065349 62197304 62268534 62268535 62270745 62299141 62299142 62299144 62312516 62318744 62320124 62320125 62326145 62329082 62330793 62330794 62332318 62332319 62332320 62360010 62370903 62376915 62376916 62377681 62389961 62389962 62389963 62397791 62332319N 62332320N 61555369 61636314 61899105 61951332 62065347 62154347 62197301 62197302 62197303 62204571 62204575 62210476 62263548 62263549 62263550 62273047 62276477 62301480 62301481 62301482 62305971 62305972 62305973 62305974 62325598 62326143 62329081 62330792 62352873 62352874 62352875 62352876 62360016 62360017 62362969 62362971 62362972 62370898 62370899 62370905 62370906 62370908 62371744 62371745 62263550N 62325598N 62326143N 62330792N 61951327 61957503 62096318 62197308 62212014 62263546 62305975 62317883 62319763 62320127 62360012 62370902 62389964 62399490 62263553 62263554 62308236 62327043 61839080 62167396 62197306 62212015 62263551 62302038 62308234 62315647 62327044 61609809 61882646 62319762 62354798 61837753 61873657 61884443 61884444 61884445 61896760 61896761 61899751 61900806 61947708 61955620 62010662 62010663 62010664 62024633 62024634 62024635 62024636 62028830 62038384 62050987 62058552 62058553 62058554 62058555 62080040 62086074 62087638 62109950 62114866 62118982 62127719 62128915 62128916 62128917 62145006 62145007 62146098 62171343 62213243 62221001 62232579 62234445 62235714 62240241 62244350 62244351 62249030 62278678 62284454 62293178 62310415 62314701 62333956 62339624 62339625 62346555 62128916N 62221001N 62232579N 62234445N 62235714N 62249030N 62278678N 62284454N 61828099 61862657 61868591 61871771 61878472 61881181 61943399 61949824 61953174 61955623 61964740 61964741 62017563 62028837 62036903 62043479 62058556 62060685 62073511 62075366 62076921 62083573 62091833 62100689 62109951 62113218 62118983 62125305 62127720 62140334 62145008 62145009 62156178 62171341 62183138 62183139 62183140 62200338 62200339 62207221 62210420 62215702 62216678 62225732 62232580 62234446 62244352 62244354 62272095 62275079 62278679 62284455 62293179 62293180 62299078 62305937 62307631 62310527 62314691 62327039 62327041 62332025 62340045 62352819 62299078N 62340045N 61694935 61881182 62028831 62036901 62036905 62046479 62050989 62050990 62060686 62060687 62065270 62065272 62076922 62097086 62106788 62114865 62125304 62134936 62137221 62140335 62148552 62154308 62156179 62172019 62172020 62193411 62193412 62199381 62200340 62200341 62210421 62218109 62220997 62222752 62227019 62240715 62256002 62257220 62261912 62281827 62284456 62291916 62291918 62309192 62309265 62314686 62314689 62328966 62332890 62340047 62281827N 62332890N 62032186 62032187 62032189 62056004 62065274 62075368 62128906 62137222 62148553 62154309 62161472 62172021 62199382 62207220 62210422 62220999 62222753 62239356 62275081 62275082 62275083 62284457 62333492 62340046 62275081N 62275082N 62275083N 62056003 62134938 62137223 62140336 62207219 62218111 62225733 62227022 62272097 62278677 62328964 62343252 62343254 62343252N |
Recalling Firm/
Manufacturer |
Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
|
| For Additional Information Contact |
Consumer Relations Call Center
800-447-5633
|
Manufacturer Reason
for Recall |
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.
|
FDA Determined
Cause 2 |
Packaging |
| Action |
Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to
1.Review the notification and ensure that relevant personnel are aware of the contents.
2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
3. Your Zimmer Biomet sales representative will remove the recalled product from your facility.
4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com.
5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative. |
| Quantity in Commerce |
10 |
| Distribution |
US Nationwide Distribution |
| Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
