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Product 47 consists of all product under product code: LPH… recallZ-1145-2016 · Zimmer Manufacturing B.V. · initiated Jan 11, 2016

Class II Terminated All recalls posted in March 2016

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Zimmer Manufacturing B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

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 root cause category: Packaging

What the company is doing

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 [email protected]. 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.

Recall details

Recall number
Z-1145-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 11, 2016
Posted by the FDA
Mar 12, 2016
Recalling firm
Zimmer Manufacturing B.V.
Quantity
30
Product code
LPH
FDA submissions
K934765
Distribution
US Nationwide Distribution

Product description

Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN 611005028 MODULAR CUP 10 DEGREE LIN 611005032 MODULAR CUP 10 DEGREE LIN 611005628 MODULAR CUP 10 DEGREE LIN 611005632 MODULAR CUP 10 DEGREE LIN 611005828 MODULAR CUP 10 DEGREE LIN 611005832 MODULAR CUP 10 DEGREE LIN 611006028 MODULAR CUP 10 DEGREE LIN 611006032 MODULAR CUP 10 DEGREE LIN 611006228 MODULAR CUP 10 DEGREE LIN 611006232 MODULAR CUP 10 DEGREE LIN 611006428 MODULAR CUP 10 DEGREE LIN 611006432 MODULAR CUP 10 DEGREE LIN 611006628 MODULAR CUP 10 DEGREE LIN 611006832 MODULAR CUP 10 DEGREE LIN 611007028 MODULAR CUP 10 DEGREE LIN 612004626 MODULAR CUP 20 DEGREE LIN 612004628 MODULAR CUP 20 DEGREE LIN 612004828 MODULAR CUP 20 DEGREE LIN 612004832 MODULAR CUP 20 DEGREE LIN 612005028 MODULAR CUP 20 DEGREE LIN 612005032 MODULAR CUP 20 DEGREE LIN 612005628 MODULAR CUP 20 DEGREE LIN 612005828 MODULAR CUP 20 DEGREE LIN 612005832 MODULAR CUP 20 DEGREE LIN 612006028 MODULAR CUP 20 DEGREE LIN 612006032 MODULAR CUP 20 DEGREE LIN 610504428 MODULAR CUP NEUTRAL LINER 610504832 MODULAR CUP NEUTRAL LINER 610505028 MODULAR CUP NEUTRAL LINER 610505032 MODULAR CUP NEUTRAL LINER 610505632 MODULAR CUP NEUTRAL LINER 610505832 MODULAR CUP NEUTRAL LINER 610506032 MODULAR CUP NEUTRAL LINER 610506232 MODULAR CUP NEUTRAL LINER For use in total hip arthroplasty

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

lot no.: 61890322 62213292 62215053 62277522 62402117 61921671 62207256 62212215 62241126 62251893 62268498 62281865 62396132 62402115 62024672 62176459 62210646 62215051 62221907 62241128 62241129 62266480 62277523 62402113 62402114 62406796 62202293 62218187 62255246 62281866 62354788 62396145 62406802 61882636 61890326 61942630 61943368 61957706 61957708 61957709 61968019 61983748 61983749 62109144 62109145 62143889 62163554 62173374 62176463 62188368 62197359 62197360 62197361 62204040 62204041 62204042 62204632 62204633 62204634 62207259 62210647 62210648 62213295 62221909 62221910 62226817 62233573 62238101 62241131 62241135 62241136 62241137 62241139 62241142 62241144 62241145 62251896 62251897 62251898 62251899 62251901 62255247 62266481 62266482 62277524 62284060 62352923 62358047 62383751 62383752 62383753 62383754 62386984 62386985 62402212 62402217 61882637 61885966 61889305 61976198 62147389 62170705 62191282 62197358 62199480 62199481 62210649 62210650 62218188 62218189 62218190 62236577 62236578 62241147 62251895 62258978 62260179 62260180 62352924 62358045 62388057 62402126 62402213 61890327 61968020 62170708 62188373 62207257 62207258 62226818 62241149 62241150 62251902 62258976 62268506 62383758 62383759 62396119 62396120 62396121 61980814 62170709 62202294 62202295 62236582 62258974 62260181 62260182 62352926 62358046 62383761 62396133 61976203 62170710 62176464 62191285 62193578 62221912 62226823 62241152 62250619 62251903 62265335 62354787 62396122 62396123 62403713 62406785 61885968 61980816 62167449 62198732 62202296 62218192 62241154 62266483 62354789 62389394 62389395 62402214 61919746 62170712 62207260 62226819 62226820 62251112 62265336 62383760 62402140 62406770 61882639 61980817 62167448 62218193 62266484 62396135 62403714 62406808 61882640 62199479 62233574 62258975 62396149 61980818 62238099 62354790 62402121 62406806 62221914 62402116 62255245 62402122 62268507 62406810 62188377 62258972 62260183 62402118 62183219 62193583 62354791 62406803 61815148 62080364 62154619 62180252 62193580 62193581 62226821 62226822 62241155 62241156 62251113 62268508 62316411 62383755 62383757 62396134 62402112 62406794 62402123 62213294 62215054 62396142 62406786 62354792 62406804 62233572 62406807 62163545 62395778 62202292 62241114 62198725 62226816 62241115 62268495 62389251 62389252 62198722 62218184 62268496 62395770 62406805 62218185 62277521 62395775 62406812 62395776 62281868

Other devices under the same FDA submission

8 devices cleared under K934765 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 72900).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page