Device recall: Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.

FDA enforcement event 78111 · Class II · initiated 19 Sep 2017 · status Terminated · terminated 21 Jun 2021

DeviceVoluntary: Firm initiated34 product recordsGainesville, FL

FDA enforcement event 78111 is a device recall by Exactech, Inc. of Gainesville, FL, initiated 19 Sep 2017 and classified Class II, with 34 product records.

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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 21 Jun 2021. Initiation: voluntary: firm initiated. Exactech, Inc. has 61 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

Exactech, Inc., Gainesville, FL.

Reason for recall

"There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray."

Distribution

"Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0126-2018	Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.	57 devices	Class II	Terminated	29 Nov 2017
Z-0127-2018	Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.	109 devices	Class II	Terminated	29 Nov 2017
Z-0128-2018	Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.	114 devices	Class II	Terminated	29 Nov 2017
Z-0129-2018	Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.	198 devices	Class II	Terminated	29 Nov 2017
Z-0130-2018	Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.	207 devices	Class II	Terminated	29 Nov 2017
Z-0131-2018	Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.	640 devices	Class II	Terminated	29 Nov 2017
Z-0132-2018	Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.	665 devices	Class II	Terminated	29 Nov 2017
Z-0133-2018	Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX.	801 devices	Class II	Terminated	29 Nov 2017
Z-0134-2018	Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX.	893 devices	Class II	Terminated	29 Nov 2017
Z-0135-2018	Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.	733 devices	Class II	Terminated	29 Nov 2017
Z-0136-2018	Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.	683 devices	Class II	Terminated	29 Nov 2017
Z-0137-2018	Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.	720 devices	Class II	Terminated	29 Nov 2017
Z-0138-2018	Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.	527 devices	Class II	Terminated	29 Nov 2017
Z-0139-2018	Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.	573 devices	Class II	Terminated	29 Nov 2017
Z-0140-2018	Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.	547 devices	Class II	Terminated	29 Nov 2017
Z-0141-2018	Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .	537 devices	Class II	Terminated	29 Nov 2017
Z-0142-2018	Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.	311 devices	Class II	Terminated	29 Nov 2017
Z-0143-2018	Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.	333 devices	Class II	Terminated	29 Nov 2017
Z-0144-2018	Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.	317 devices	Class II	Terminated	29 Nov 2017
Z-0145-2018	Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.	306 devices	Class II	Terminated	29 Nov 2017
Z-0146-2018	Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .	643 devices	Class II	Terminated	29 Nov 2017
Z-0147-2018	Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX.	840 devices	Class II	Terminated	29 Nov 2017
Z-0148-2018	Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX.	889 devices	Class II	Terminated	29 Nov 2017
Z-0149-2018	Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.	920 devices	Class II	Terminated	29 Nov 2017
Z-0150-2018	Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.	953 devices	Class II	Terminated	29 Nov 2017
Z-0151-2018	Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.	895 devices	Class II	Terminated	29 Nov 2017
Z-0152-2018	Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX.	606 devices	Class II	Terminated	29 Nov 2017
Z-0153-2018	Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.	656 devices	Class II	Terminated	29 Nov 2017
Z-0154-2018	Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.	575 devices	Class II	Terminated	29 Nov 2017
Z-0155-2018	Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.	537 devices	Class II	Terminated	29 Nov 2017
Z-0156-2018	Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.	520 devices	Class II	Terminated	29 Nov 2017
Z-0157-2018	Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.	386 devices	Class II	Terminated	29 Nov 2017
Z-0158-2018	Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.	411 devices	Class II	Terminated	29 Nov 2017
Z-0159-2018	Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.	678 devices	Class II	Terminated	29 Nov 2017

Context

93%of 2017 device events are Class II1,091 events that year

34product records in this eventfirm median: 1

61events on this register for the firm

Other enforcement events for Exactech, Inc.

Initiated	Product (first record)	Type	Class	Records
3 Feb 2026	Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05	Device	Class II	2
5 Sep 2025	Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Vers	Device	Class II	3
15 Aug 2025	Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38	Device	Class II	2
31 Dec 2024	AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-2	Device	Class II	3
26 Apr 2024	Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ.	Device	Class II	1
18 Apr 2024	OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM	Device	Class II	4
6 Mar 2024	Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 3	Device	Class II	24
21 Nov 2023	AcuMatch Hip System, Catalog Number 142-32-27	Device	Class II	12
5 Jun 2023	Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.	Device	Class II	2
11 Aug 2022	GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E	Device	Class II	10

All 61 events for Exactech, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray."

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: "Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 21 Jun 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.