CLASS II Device recall · Reported 25 Jan 2017 · FDA Enforcement Report
AcuMatch A-Series Connexion GXL Enhanced Polyethylene recalled
Exactech is recalling AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, + Lateralized, distributed in 13 states. The recall was initiated on 7 Nov 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1031-2017
- FDA event ID
- 75989
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Nov 2016
- FDA classified
- 17 Jan 2017
- Reported
- 25 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 7 Nov 2016 | Recall initiated by company | |
| 17 Jan 2017 | Classified by FDA | +71 days |
| 25 Jan 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Product as listed by the FDA
AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
Where it was distributed
AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
ArizonaCaliforniaColoradoFloridaIllinoisKansasMarylandNew JerseyNew YorkOhioOklahomaTennesseeVirginia
Questions about this recall
Why was it recalled?
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Which lots are affected?
Serial No. 4507932-4507943; Catalog No. 138-36-29; UDI: 10885862024831
Where was it sold?
AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 75989| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size recalled | Exactech | Other | 13 states | |
| CLASS II | Novation Cemented Plus Femoral Stem, 12/14, Collared recalled | Exactech | Other | 13 states |
More recalls from Exactech
All 197| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Equinoxe Core Instrument Kit recalled by Exactech | Exactech | Other | 19 states |
| Device | CLASS II | Equinoxe Ergo Modular Impactor Handle recalled by Exactech | Exactech | Other | 19 states |
| Device | CLASS II | Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech | Exactech | Device Malfunction | SC |
| Device | CLASS II | Equinoxe Ergo Augments Pilot Tip Converter recalled by Exactech | Exactech | Device Malfunction | SC |
| Device | CLASS II | Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech | Exactech | Device Malfunction | SC |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |