Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003
FDA device recall Z-2753-2011 · posted 2011-07-07 · Terminated
Recall details
- Recalling firm
- Kapp Surgical Instrument Inc
- Reason for recall
- During an FDA Inspection on 3/21/11 - 3/22/11 at Kapp Surgical an uncontrolled instruction for use was discovered which contained sterilization parameters which differed from the instructions contained in the device master record. Kapp Surgical decided to conduct the recall because we cannot be sure that incorrect instructions were not shipped.
- Action taken
- Kapp Surgical Instrument, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory and quarantine any product affected by this recall. The firm will make arrangements for returning the products. Replacements will be made by Kapp Surgical. Questions about this recall are directed to the QA Manager at 800-282-5277.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- NEU
- Quantity affected
- 222 units (rings)
- Distribution
- Product was distributed to the following states: OH, PA & SC. Product was also shipped to Saudia Arabia.
- Date initiated
- 2011-05-24
- Date posted
- 2011-07-07
- Date terminated
- 2013-02-19
- Location
- Warrensville Heights, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 (K072216) | Kapp Surgical Instrument, Inc. | 2007-11-09 |