Recall Z-0533-2020
Zimmer Biomet, Inc. · initiated August 21, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
Codes / lots: LOTS 584440 823130 966710 653720 191230 361690 917170 993450 009590 971720 197730 421300 970590 799740 713840 265680 924350 729030 843020 729020 034400 279060 958550 451520 040360 364420 399470 417590 446550 449550 489790 572090 587200 609410 616720 965280 975560 996130 873200 287000 951480 031170 659320 830600 297280 407350 907020 751730 641070 713850 729050 729040 960150 957220 451540 299920 564400 150450 770600 364540 146250 761320 957590 868620 537430 810590 364560 UDI (01)00887868226441(17)270911(10)823130 (01)00880304804180(17)251120(10)966710 (01)00880304860001(17)270228(10)191230 (01)00880304443044(17)230220(10)265680 (01)00880304443044(17)230315(10)729030 (01)00880304443044(17)230319(10)843020 (01)00880304443044(17)230328(10)729020 (01)00880304443044(17)230430(10)034400 (01)00880304443044(17)230520(10)279060 (01)00880304443044(17)230816(10)958550 (01)00880304443044(17)240212(10)451520 (01)00880304434127(17)230319(10)729050 (01)00880304434127(17)230328(10)729040 (01)00880304434127(17)230408(10)960150 (01)00880304434127(17)230816(10)957220 (01)00880304434127(17)240221(10)451540 (01)00880304434127(17)240714(10)299920 (01)00880304434127(17)250319(10)564400…
Reason for recall
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
FDA-determined cause: Environmental control
Action taken
On September 11, 2019, the firm began notifying distributors and customers of the recall via an Urgent Medical Device Recall letter. The letter informed consignees of the product issue. Customers were asked to assist their Zimmer Biomet sales representative and quarantine all identified product. The sales representative will remove the product from your facility. If any products were further distributed, please forward the notification to responsible parties. If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00 pm ET, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
Details
- Recall number
- Z-0533-2020
- Initiated
- August 21, 2019
- Terminated
- July 21, 2021
- Product code
- MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Quantity
- 214741
- Distribution
- US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.
- Recalling firm
- Zimmer Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0519-2020 Class II | Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0520-2020 Class II | COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0521-2020 Class II | ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0522-2020 Class II | HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0523-2020 Class II | Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0524-2020 Class II | Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/AElevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0525-2020 Class II | Comprehensive RS Cleat CAP, Item No. 110300Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0526-2020 Class II | Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0527-2020 Class II | Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0528-2020 Class II | HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0529-2020 Class II | GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0530-2020 Class II | BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0531-2020 Class II | 2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0532-2020 Class II | LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |