Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Reported: May 6, 2015 Initiated: March 18, 2015 #Z-1523-2015
Product Description
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Reason for Recall
Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.
Details
- Recalling Firm
- Zimmer Gmbh
- Units Affected
- 30 units
- Distribution
- Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
- Location
- Winterthur
Frequently Asked Questions
What product was recalled? ▼
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.. Recalled by Zimmer Gmbh. Units affected: 30 units.
Why was this product recalled? ▼
Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2015. Severity: Moderate. Recall number: Z-1523-2015.
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