CLASS II Device recall · Reported 27 Jun 2018 · FDA Enforcement Report
G-pin 8bl 2pl recalled by Zimmer Biomet
Zimmer Biomet is recalling G-pin 8bl 2pl, distributed nationwide in the US. The recall was initiated on 16 May 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-2237-2018
- FDA event ID
- 80193
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 May 2018
- FDA classified
- 15 Jun 2018
- Reported
- 27 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 16 May 2018 | Recall initiated by company | |
| 15 Jun 2018 | Classified by FDA | +30 days |
| 27 Jun 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
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
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
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Where it was distributed
Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.
Questions about this recall
Is G-pin 8bl 2pl recalled?
Yes. Zimmer Biomet recalled G-pin 8bl 2pl on 16 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2237-2018.
Why was it recalled?
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
Which lots are affected?
286530 300210 413620 448170 548100 570250 626810 638980 700950 758900 828020 828040 932250 244880 244890 125970 150380 298880 754180 571170 198490 800020 399250
Where was it sold?
Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.
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 21 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 Zimmer Biomet
All 873| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Spinal Rod Cutter recalled by Zimmer Biomet | Zimmer Biomet | Sterility | Nationwide |
| Device | CLASS II | Polaris 5 Spinal System and Polaris 5/Cypher Spinal System recalled | Zimmer Biomet | Device Malfunction | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D. recalled | Zimmer Biomet | Sterility | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Sterility | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |