CLASS II Device recall · Reported 14 Nov 2018 · FDA Enforcement Report
Sterile Knee Instruments Disposable Fluted Headless Pins, DIA LNTH recalled
Howmedica Osteonics is recalling Sterile Knee Instruments Disposable Fluted Headless Pins, DIA LNTH, distributed nationwide in the US. The recall was initiated on 10 Sep 2018 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-0373-2019
- FDA event ID
- 81192
- Recalling firm
- Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Sep 2018
- FDA classified
- 2 Nov 2018
- Reported
- 14 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 10 Sep 2018 | Recall initiated by company | |
| 2 Nov 2018 | Classified by FDA | +53 days |
| 14 Nov 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for outer pouch sterile barrier to be compromised
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee, shoulder, elbow or wrist arthroplasty, or trauma surgeries.
Where it was distributed
US Nationwide in the states of AL, FL, IL, MI, NJ & OH.
Questions about this recall
Why was it recalled?
Potential for outer pouch sterile barrier to be compromised
Which lots are affected?
Lot SC22130X Exp 2023-08-05
Where was it sold?
US Nationwide in the states of AL, FL, IL, MI, NJ & OH.
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.
More recalls from Howmedica Osteonics
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|---|---|---|---|---|---|
| Device | CLASS II | Tri Ts Baseplate Size recalled by Howmedica Osteonics | Howmedica Osteonics | Packaging Defects | Nationwide |
| Device | CLASS II | Tri Ts Baseplate Size recalled by Howmedica Osteonics | Howmedica Osteonics | Packaging Defects | Nationwide |
| Device | CLASS II | MICS3 Angled Sagittal Saw Attachment recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | The Stryker CranialMask Tracker is a single-use device recalled | Howmedica Osteonics | Device Malfunction | Nationwide |
| Device | CLASS II | Exeter V40 Stem No recalled by Howmedica Osteonics | Howmedica Osteonics | Packaging Defects | NJ |
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 |