Food, drugs, devices › Zimmer Biomet, Inc.
Device recall: Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 1
Zimmer Biomet, Inc. (Warsaw, IN) initiated this device recall on 21 Aug 2019; FDA lists 15 product records under event 83783, classified Class II.
FDA defines Class II as 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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 21 Jul 2021. Initiation: voluntary: firm initiated. Zimmer Biomet, Inc. has 144 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Zimmer Biomet, Inc., Warsaw, IN.
Reason for recall
"Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue."
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0519-2020 | Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733… | 219988 units | Class II | Terminated | 4 Dec 2019 |
| Z-0520-2020 | COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM555160 PM555209 PM555322 PM555406 PM555415 UDI: (01)00880304475342(17)211128(10)704850 (01)00880304475342(17)220128(10)094500… | 219988 units | Class II | Terminated | 4 Dec 2019 |
| Z-0521-2020 | ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement. | 219988 units (total) | Class II | Terminated | 4 Dec 2019 |
| Z-0522-2020 | HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder. | 219988 units (total) | Class II | Terminated | 4 Dec 2019 |
| Z-0523-2020 | Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211 21-103212 21-103215 21-104109 21-104110 21-104111 21-104112 21-104113 21-104114 21-104115 21-104116 21-104117… | 219988 units (total) | Class II | Terminated | 4 Dec 2019 |
| Z-0524-2020 | Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A | 219988 units (total) | Class II | Terminated | 4 Dec 2019 |
| Z-0525-2020 | Comprehensive RS Cleat CAP, Item No. 110300 | 219988 units (total) | Class II | Terminated | 4 Dec 2019 |
| Z-0526-2020 | Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102948 CP112662 CP112663 CP112664 CP112674 CP112675 CP113771 CP113777 CP113778 CP113782 CP113783 CP114083 CP114090 CP114112 CP114118 CP114148 CP114213 CP114388 CP114436 CP114463 CP114472 CP114478 CP114495… | 219988 units (total) | Class II | Terminated | 4 Dec 2019 |
| Z-0527-2020 | Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement. | 219988 units (total) | Class II | Terminated | 4 Dec 2019 |
| Z-0528-2020 | HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020… | 178886 | Class II | Terminated | 4 Dec 2019 |
| Z-0529-2020 | GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices. | 2468 | Class II | Terminated | 4 Dec 2019 |
| Z-0530-2020 | BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices. | 1729 | Class II | Terminated | 4 Dec 2019 |
| Z-0531-2020 | 2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices. | 2708 | Class II | Terminated | 4 Dec 2019 |
| Z-0532-2020 | LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718… | 217240 | Class II | Terminated | 4 Dec 2019 |
| Z-0533-2020 | BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement | 214741 | Class II | Terminated | 4 Dec 2019 |
Context
Other enforcement events for Zimmer Biomet, Inc.
All 144 events for Zimmer Biomet, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Jul 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.