Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH BOTTOM, +0MM TASP L GH BOTTOM, +6MM TASP L J BOTTOM, +0MM TASP L J BOTTOM, +6MM TASP R CD BOTTOM, +0M
Check against the official notice below — it lists the full affected range.
Zimmer, Inc. recalled Persona Knee Trial Articular Surface Provisionals (TASPs) used in knee replacement procedures after receiving complaints about breakage of these trial components. The recall covers specific item numbers and lot numbers distributed worldwide, including throughout the United States, Puerto Rico, and several international locations including Canada, Australia, Japan, Germany, India, Korea, and Singapore. A total of 70,986 distribution events were affected by this retrospective recall, which covers corrective actions Zimmer took earlier in the year.
The record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.
Reason for recall: Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs. Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore. Quantity: 70,986 distribution events Lot/code info: Item Numbers: 42517000303 42517000313 42517000505 42517000515 42517000707 42517000717 42517000909 42517000919 42527000303 42527000313 42527000505 42527000515 42527000707 42527000717 42527000909 42527000919 Lot Numbers: 62022340 62024973 62062232 62104367 62187314 62187315 62190367 62190370 62265725 62301862 62314675 62385126 62385132 62355857 62403987 62414017 62420244 62456269 62506026 62506044 62531664 62558106 62564325 62596552 62600208 62614790 62683419 62691385 62698730 62716777 62024974 62032099 62075271 62144791 62171682 62171684 62184223 62187317 62239237 62256256 62248153 62386757 62391108 62414001 62391109 62414002 62456271 62474902 62544384 62565107 62565106 62601564 62612269 62627270 62678888 62684675 62695301 62710627 62745014 62019862 62091183 62177238 62177239 62177240 62268818 62282708 62305406 62314683 62351287 62356123 62385455 62401419 62405946 62419059 62429198 62456279 62504887 62531665 62559945 62565049 62595861 62621822 62627202 62663169 62690886 62696853 62698724 62716769 62710616 62030854 62050136 62125572 62154284 62165540 62168382 62177242 62190375 62247344 62247345 62256257 62364951 62391110 62413998 62391111 62427064 62413999 62469454 62525495 62538399 62565110 62565111 62565109 62595858 62630285 62632817 62680122 62680123 62691389 62696886 62710624 62717356 62022342 62024977 62087042 62091198 62165542 62189343 62187321 62233919 62239239 62256279 62247347 62386756 62391114 62391115 62403989 62419057 62429191 62461234 62525494 62544359 62564327 625
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.