Z-2309-2024Class II
ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S
American Contract Systems, Inc. / initiated 2024-05-15 / Open, Classified
American Contract Systems Inc began a recall of ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S on . FDA classified it as Class II and gives the reason as "Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-2309-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- American Contract Systems, Inc.
- Product
- ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S
- Product code
- OJH Orthopedic Tray
- Reason for recall
- Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- FDA root cause
- Under Investigation by firm
- Action
- American Contract Systems issued Urgent Voluntary Recall Letter (FA-2024-018) via email on 5/15/24 to Distributors. Distributors to notify end-users. Letter states reason for recall, health risk and action to take: Immediately discontinue use of the cast padding component (DISCARD ITEM 4927009046-CAST PADDING, 6" Cotton Blend Rayon) included in each kit/tray identified in ATTACHMENT 1. Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. "Add warning labels to all kits/cases impacted: A labeling template is enclosed for printing warning labels which should be affixed to all affected product in inventory. This label should be affixed to each affected kit and case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing labeling. "Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. "Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. "Complete the enclosed Response Form and return as soon as possible. "If credit is requested, please send an email to [email protected].
- Quantity in commerce
- 28 units
- Distribution
- US Nationwide distribution.
- Product codes and lots
- UDI-DI: 00191072154934 LOT#"s: 639231 936241
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2274-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2275-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2276-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2277-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2278-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2279-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2280-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2281-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2282-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2283-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2284-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2285-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2286-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2287-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2288-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2289-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2290-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2291-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2292-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2293-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2294-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2295-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2296-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2297-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2298-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2299-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2300-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2301-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2302-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2303-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2304-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2305-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2306-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2307-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2308-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2309-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2310-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2311-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2312-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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