Device recall: BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817…
Class II FDA enforcement event 83962. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Zimmer Biomet, Inc. started this device recall on 10 Oct 2019. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 83962 has 41 product records. The first FDA enforcement report date is 13 Nov 2019. The record gives the status Terminated, with the termination date 19 May 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distributed nationwide.
Recalling firm
Zimmer Biomet, Inc., Warsaw, IN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
41 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0298-2020 | BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417 00430001420 00430001513 00430001613 00430001713 00430001813… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0299-2020 | Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434211313 00434211413 00434211417 00434211513 00434211613 00434211713 00434211813 00434810613 00434810813 00434810817 00434810913… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0300-2020 | Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520 0104555525 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0301-2020 | Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012 32810600013 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510822 32855510843 32855510844 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0302-2020 | Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339 32855090348 32855090351 32855090352 32855090353… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0303-2020 | NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0304-2020 | NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009 0202264012 0202264015 0202264018 0202264021 0202264109 0202264112 0202264115 0202264118 0202264121 0202265010 0202265012… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0305-2020 | ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 00234701610 00234701612 00234701614 00234701616 00234701702 00234701704 00234701706 00234701708 00234701710 00234701712 00234701714 00234701716 00234701718 00234701802 00234701804… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0306-2020 | TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 00450002500 00450002600 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0307-2020 | Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 00234700406 00234700408 00234700410 00234700412 00234700414 00234700416 00234700502 00234700504 00234700506 00234700508 00234700510 00234700512 00234700514 00234700602 00234700604… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0308-2020 | PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112 00234700114 00234700116 00234700118 00234700206 00234700208 00234700210 00234700212 00234700214 00234700216 00234700218 00234703104 00234703106 00234703108 00234703204 00234703206 00234703208 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0309-2020 | Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 47235700408 47235700410 47235700412 47235700414 47235700416 47235700504 47235700506 47235700508 47235700510 47235700512 47235700514 47235700518 47235700604 47235700606 47235700608 47235700610… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0310-2020 | DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 47235710222 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0311-2020 | SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 47235802204 47235802206 47235802208 47235802210 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0312-2020 | Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 47492800613 47492800702 47492800703 47492800707 47492800802 47492800803 47492800807 47492800813 47492800902 47492800907 47492801002 47492801007… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0313-2020 | PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 00234800116 00234800204 00234800206 00234800208 00234800210 00234800212 00234800214 00234800216 00234800304 00234800306 00234800404 00234800408 00234800412 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0314-2020 | Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504 00234800506 00234800508 00234800510 00234800512 00234800514 00234800604 00234800606 00234800608 00234800610 00234800612 00234800614 00234800712 00234800714 00234800716 00234800902 00234800904 00234800906 00234800908 00234800910 00234800912… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0315-2020 | PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 00234801308 00234801310 00234801312 00234801403 00234801404 00234801406 00234801408 00234801410 00234801412 00234802102 00234802104 00234802106 00234802108 00234802110 00234802112 00234802204 00234802206 00234802208… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0316-2020 | PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 47235800208 47235800212 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0317-2020 | Periarticular locking plate elbow-sterile, Item Nos. 47235800503 47235800509 47235800511 47235800515 47235800519 47235800603 47235800605 47235800607 47235800609 47235800611 47235800615 47235800619 47235800705 47235800711 47235800715 47235800803 47235800805 47235800807 47235800811 47235800815 47235800911 47235800913… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0318-2020 | Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636 00151504836 00151505040 00151505240 00151505444 00151505644 00151505848 00151506048 00151506248 00151506448 00151506648 00400500060 00401000038 00401000040 00401000041 00401000042 00401000043 00401000044 00401000045 00401000046… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0319-2020 | CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112 0100296125 0100296137 0100296150 0100296162 0100296175 0100296200 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0320-2020 | Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 0100551105 0100551106 0100551107 0100551108 0100551109 0100551110 0100551111 0100551112 0100551113 0100551114 0100551201 0100551202 0100551203 0100551204 0100551205 0100551206 0100551207 0100551208 0100551209 0100551210… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0321-2020 | Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800 00522006900 00522007000 00522007200 00522007300 00522007400 00522007500 00522007900 00522008000 00522400800 00522400900 00522406201 00541001401… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0322-2020 | Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 00597909541 00597909546 00597909551 00598304027 00598304033 00598304048 00598304148 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0323-2020 | Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00585004606 00585004608 00585004610 00585004612… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0324-2020 | LPS-MOB ART SURF IMPL D 9MM | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0325-2020 | Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315 32855430491 32855430497 32855430499 32855430500 32855430502 32855430503 32855430511 32855430526 32855430530 32855430531 32855430536 32855430537 32855430538 32855430539… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0326-2020 | Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118100565 00118100567 00118101022 00118101025 00118101027 00118101030 00118101032 00118101035 00118101037 00118101040 00118101042… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0327-2020 | CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0328-2020 | Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 00224000930 00224000932 00224000934 00224000936 00224000938 00224000940 00224000942 00224000944 00224000946 00224001014 00224001016 00224001018 00224001020 00224001022 00224001024… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0329-2020 | Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024342 0202024344 0202024346 0202024360 0202024362 47225806700 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0330-2020 | Connection Screw for NCB Plate, Item No. 0202266002 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0331-2020 | NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0332-2020 | NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0333-2020 | FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115 32855331161 32855331163 32855331165 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0334-2020 | Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877000732 00877000832 00877000936 00877001036 00877001140 00877001240 00877001340 00877001440 00877001540 00877001640 00877001740 00877001840 00877001940 00877002040 00877002140 00877002240 00877002340 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0335-2020 | Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0336-2020 | Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004 | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0337-2020 | Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011 47249318013 47249318014 47249318109 47249318110 47249318111 47249318113 47249318114 47249318209 47249318210 47249318211 47249318213 47249318214 47249318309 47249318310 47249318311 47249318313 47249318314 47249321010 47249321011… | 5,459,583 total devices | Class II | Terminated | 13 Nov 2019 |
| Z-0338-2020 | cable button for NCB Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001 | 5459583 total devices | Class II | Terminated | 13 Nov 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 41Median of the firm: 1
- Events of the firm on the register
- 144
Other events of the firm
Official channels
- FDA enforcement report Z-0298-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 83962. https://recallregister.com/fda/ii/83962/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distributed nationwide.
- What quantity of product is in FDA event 83962?
- The event has 41 product records. The first record gives this quantity:
5,459,583 total devices
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.