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Spica Table
ORTHOPEDIATRICS CORP. · Model 03-1006-0502 · UDI-DI 00841132136331
JEB
Prescription
10
510(k) clearances
79
Adverse events
11
Recalls
43
Facilities
Description
BACK BOARD HANDEL, SPICA TABLE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-04-16 | Zimmer Surgical Inc | Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II Base Plate and Foot Piece due to potentially inadequate cleaning procedures |
| 2017-10-06 | Allen Medical Systems | The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame. |
| 2017-10-06 | Allen Medical Systems | The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame. |
| 2017-09-07 | Zimmer Biomet, Inc. | Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution. |
| 2016-09-27 | Schaerer Medical USA Inc | The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak. |
| 2016-09-27 | Schaerer Medical USA Inc | The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables. The cylinders were manufactured with the incorrect "O" ring which may cause the cy |
| 2013-10-28 | Trumpf Medical Systems, Inc. | The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame. |
| 2007-11-23 | Tenet Medical Engineering Inc | Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised. |
| 2007-11-23 | Tenet Medical Engineering Inc | Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised. |
| 2007-11-23 | Tenet Medical Engineering Inc | Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.