Z-2072-2015Class II
A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument
Zimmer GmbH / initiated 2015-06-17 / Terminated / root cause: supplier
Biomet, Inc. began a recall of A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument on . FDA classified it as Class II and gives the reason as "Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.
Recall record
- Recall number
- Z-2072-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
- Product code
- HYA Forceps, Wire Holding
- Reason for recall
- Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.
- Root cause tag
- supplier
- FDA root cause
- Vendor change control
- Action
- On 6/17/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for locating and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
- Quantity in commerce
- 223
- Distribution
- Domestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica
- Product codes and lots
- Part Number: 816301006 Lot Numbers: 099216, 093776, 093717, 093716, 088526, 081179, 072525, 072524
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2072-2015 | Class II | Terminated | Voluntary: Firm initiated |
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